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4 weeks ago

Staff Specialist, Compliance

Thermo Fisher Scientific - Carlsbad, CA 92008

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description COMPANY: Thermo Fisher Scientific, Inc. LOCATION: 5781 Van Allen Way, Carlsbad, CA 92008 TITLE: Staff Specialist, Compliance HOURS: Monday to Friday, 8:00 am to 5:00 pm DUTIES: Ensure compliance with applicable local, state, federal, and international regulations and standards (e.g., FDA, ISO, GMP). Stay current with changes in regulatory requirements and industry standards and disseminate relevant information to the organization. Create and oversee self-inspection program, perform Internal Audits, and lead all aspects of functional walk-throughs to ensure compliance to corporate directives, site procedures, and regulatory expectations. Conduct risk assessments related to product quality and regulatory compliance and implement risk mitigation strategies and monitor their effectiveness. Prepare and maintain detailed reports, records, and documentation related to compliance activities. Lead Audit Readiness through design and execution of risk management program including communication risk register and risk mitigation strategy to the Quality Head and Site Leadership Team to ensure the site is inspection ready at all times. Host Regulatory Inspections, Corporate audits, and client audits. Collaborate with clients, auditors, and regulator agents and represent the site during inspectors and meetings to ensure information is provided in a timely, accurate, and complete manner. Responsible for timely and effective execution of both internal and external audit commitments. Interact with SMEs in all functional areas to lead the development and implementation of Corrective and Preventative Actions (CAPAs) in response to any audit/inspection findings. Collect, analyze, trend, and report-out-monthly on quality for measurement of compliance risk to able to drive initiatives to mitigate those risks. Partner with Regulatory to assess new or revised regulations and standards to ensure organization fulfill changing regulatory and industry needs. Assess updates to Corporate Policies, SOPs, and Guidance Documents for impact to site procedures and ensures timely closure of gaps. Ensure that the site quality systems are accurately supported to ensure compliance with applicable standards. Support in change controls activities for document and manufacturing processes. Identify opportunities for process improvements and lead initiatives to enhance quality and compliance. Develop and deliver training program on quality and compliance topics for staff at all levels. TRAVEL: Up to 10% domestic and international travel required. REQUIREMENTS: Bachelor’s degree or foreign degree equivalent in Industrial Engineering, Biomedical Engineering, Biotechnology, or related field of study plus 7 years of experience as a Quality Engineer, Quality Specialist, Complaints Analyst, or any occupation in which the required experience can be obtained, or related experience. Employer will also accept a Master’s degree or foreign degree equivalent in Industrial Engineering, Biomedical Engineering, Biotechnology, or related field of study plus 5 years of experience as a Quality Engineer, Quality Specialist, Complaints Analyst, or any occupation in which the required experience can be obtained, or related experience. Required knowledge or experience with: 21CFR 820, ISO9001:2015; Analyzing complex regulations and their impact on business operations; Quality Management System design and oversight; Reviewing documents and processes to ensure compliance; Conveying compliance information to various stakeholders in global leadership; Identifying compliance issues and developing effective solutions; Overseeing the resolution of compliance issues and implementation of corrective actions; Identifying process gaps and driving continuous improvement initiatives to enhance performance; Hosting customers and notified body audits and regulatory inspections, ensuring effective communication with auditors/inspectors; Auditing skills, including ability to plan, execute, and report on internal and external audits; Application of quality tools: Risk Analysis, Root Cause Analysis; Compliance specific software programs: OCPLM, Trackwise, LIMS, ERP; Statistical methods and tools to analyze quality systems data, identify trends, and support decision-making processes; and Ethically handling confidential information. Salary: $142,174 to $158,500 per year Compensation and Benefits The salary pay range estimated for this position Staff QA Engineer based inCalifornia is $142,147.00–$158,500.00. This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes: A choice of national medical and dental plans, and a national vision plan, including health incentive programs Employee assistance and family support programs, including commuter benefits and tuition reimbursement At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards

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4 weeks ago

Validations, Maintenance and Calibrations Specialist

Grifols - Vista, CA 92083

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. Summary: Fully on-site role is embedded within the manufacturing team and is responsible for ensuring equipment and system readiness through validation, calibration, and preventive maintenance. The specialist must operate autonomously, lead validation efforts, and collaborate closely with R&D on new project implementation. This role will not only be dedicated to the Vista facility but providing validation support to all GBS locations and processes. Primary Responsibilities: Validations Schedule and perform validation studies to meet production and requalification, IQ, OQ, PQ, CV, and PV requirements. This position requires giving instruction to personnel in other departments over which he/she has no direct authority. Advise production managers and supervisors in the performance of validation activities and adapt the validation schedule to production requirements Coordinate validation activities with managers, supervisors, and technicians/operators from R&D, Manufacturing, Quality, Instrumentation, GMP, and Engineering Develop qualification and validation protocols/reports for manufacturing systems, processes, and equipment such as qualification/requalification, facilities, utilities, temperature-controlled areas, cleaning, etc. This position requires thorough knowledge of processes, equipment, and sterilization principles and concepts. This knowledge is used in the implementation of the "life cycle" approach to validation. Evaluate and analyze validation data collected during projects, verify adequacy of the information and compliance with regulations. validation-related activities of production, calibration, maintenance, quality, and others Perform pre and post calibrations of thermal monitoring equipment, place probes, and generate reports and graphs of data Perform routine requalification’s on schedule, including writing protocols, performing validation runs, analyzing data, writing reports, and assembling final validation packets Maintain accurate, succinct, and detailed documentation of activities and ensure paperwork from other departments is available and complete when required Ensure paperwork from other departments is available and complete when required Assist GMP, Quality, and various production personnel during inspections or audits conducted by internal groups or regulatory agencies Onboarding new equipment: coordinate/ lead creation of SOPs ensuring all operational, maintenance and calibration aspects are included Maintenance & Calibrations Maintain full oversight of all equipment in the facility requiring preventive maintenance and calibration SOP oversight for existing equipment ensuring preventive maintenance and calibration required is clearly stated in existing operating procedures Serve as the key liaison between manufacturing and third-party providers to ensure proper maintenance and calibration is carried out Knowledge, Skills, and Abilities: Strong knowledge of current Good Manufacturing Practices (cGMPs) operating procedures, validation standards and guidelines, and standard operating procedures. Certification in validation or maintenance management (e.g., ASQ, CMRT) as a plus. Strong critical thinking and problem-solving skills. Ability to identify errors and provide corrective action. Ability to work with others in a team environment. Proficiency with data acquisition systems and thermal mapping tools. Strong quantitative, analytical, organizational, and communication skills. Ability to lead projects and proactiveness will be required. Education and Experience: Requires a BS/BA degree in related field, such as STEM (Science, Technology (i.e. Industrial Technology), Engineering, and Mathematics). An equivalent combination of education and experience may be considered based on business need. Minimum 5 years in validations within a GMP-regulated manufacturing environment. Experience in maintenance and calibrations will be highly valued. Pay scale of $103,270.00 - $154,790.00 per year depending on training, education and experience. This position is eligible to participate in up to 8% of the company bonus pool. We offer benefits including medical, PTO, up to 5% 401K match, and tuition reimbursement. We are committed to offering our employees opportunities for professional growth and career progression. Even though we are a global healthcare company with employees in 30 countries, Grifols prides itself on its family-like culture. Our company has more than tripled its workforce in the last 10 years — we’re growing, and you can grow with us! Third Party Agency and Recruiter Notice: Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate. Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws, including but not limited to, the California Fair Chance Act, the Los Angeles County Fair Chance Ordinance for Employers, and the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance. Location: NORTH AMERICA : USA : CA-Vista:[[cust_building]] Learn more about Grifols

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4 weeks ago

QA Technician 1

Natural Alternatives International - Vista, CA 92081

Since 1980, NAI has been a leader in nutritional health, bringing whole food-based supplements to a global population. NAI is a leading expert and manufacturer of dietary supplements, and we are involved in every facet of the industry, including research, development, manufacturing, marketing, and advocacy. As a company, we continue to grow with manufacturing locations in Vista and Carlsbad, CA. We are looking for seasoned and entry level candidates that are interested in working for global company with opportunities for growth, development, competitive pay, and benefits. Benefits: Medical plan options – Two HMO and one PPO Dental, vision, life insurance and other voluntary benefit options. 3 weeks’ vacation and 11 paid holidays 401K including company matching and profit sharing $1,000 Employee Referral Bonus Quarterly employee lunches, Employee of Month and other recognition programs Opportunities for advancement Comprehensive training Tuition Reimbursement and more! Summary Quality Assurance Technician 1 is responsible for the inspection of Raw Materials to ensure conformance to specifications. Essential Duties & Responsibilities Inspect raw materials at receipt to verify conformance to specifications. Reviews Supplier C of A’s against NAI specifications. Determines when testing is due based on testing history and NAI specification testing frequencies. Takes samples of raw materials using statistical sampling plan and utilizing aseptic techniques. Performs physical inspection and testing, as required, such as identity testing using FT-IR analyzer, loose and/or tapped density, Loss on Drying using a moisture analyzer, sieve analysis using various screens with Ro-tap equipment and irradiation screening using PPSL equipment. Perform secondary review of inspection documentation. Release conforming material for production use. Complete and file required documentation. Communicates inspection failures and non-conformances to QA Coordinator. Follows management instructions for handling non-conforming material or product. Understands and follows company procedures and policies for inspecting materials and finished products established in compliance with the 21 CFR 111, Dietary Supplement cGMP. Understands and follows written instructions provided in company procedures and specifications. Notifies QA Management of any deviations to the procedure or specifications. Obtains instructions and approval for handling deviation prior to initiating action. Able to communicate and interact effectively with Purchasing, Planning, R & D, Distribution, Inventory Control, Operations, Client Services and Quality personnel. Maintain a sanitary working environment. Control & coordinate the movement of material. Assists with Raw Material Retain management Assists with Temperature and Humidity Monitoring Program. Assists with Raw Material quarantine cage maintenance. Performs other jobs as requested. Qualifications Education & Experience Minimum: High School Diploma with 2 years Quality experience, or BA/BS degree in biology, chemistry, engineering or applicable physical science. Proven knowledge of interpreting microbiological and analytical test results reported on C of A’s. Proven knowledge and ability to conduct and interpret inspection criteria, data, and results. Strong communication skills and the ability to follow both written and verbal instructions. Ability to document information completely and accurately. Proven organizational skills and task management ability. Good computer skills, with knowledge of Microsoft word, access, and excel. Physical Demands While performing the duties of this job, the employee is regularly required to walk; use hands to finger, handle, or feel; reach with hands and arms; stoop and kneel; talk and hear. The employee is frequently required to sit and stand. Specific vision abilities required by this job include close vision, color vision, peripheral vision, depth perception, and the ability to adjust and focus. Lifting requirement: Up to the maximum safety-recommended 50 pounds The physical demands are representative of those that must be met by employee to successfully perform the essential functions of this job. Reasonable accommodation may be made upon request to enable individuals with qualified disabilities to perform the essential functions of the job. Training Standard Operating Procedure training required upon initial new hire training, annually, and as SOP’s are updated, annual HACCP and GMP training requirement with assessment. Decision Making Employee will make decisions related to raw material evaluations and conformance with specifications. Communication Employee must demonstrate strong communication skills both written (via email and memo) and verbal. Employee will be required to communicate with QA Management and multiple NAI departments. Results of Action Decisions on the status of raw materials will determine if material is acceptable for use. Equipment Used FT-IR (ID testing), Sampling tools, pallet jack, scales, hydraulic carts, particle size analyzer, PPSL tester, bulk density/tapped density tester, moisture analyzer, disintegration equipment, cylinders, weigh pans, petri dishes, personal computer and multiple printers. Work Environment Production facility with exposure to computerized equipment, moving mechanical parts, forklifts, heavy pallets, moderate to loud noise level, and air-borne dust and powders. While working, will be required to wear various personal protective equipment (e.g., clothing, hair net, face mask, gloves, goggles, etc.). NAI is an Affirmative Action/Equal Opportunity Employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, physical or mental disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. Following a conditional offer of employment, satisfactory completion of a background check (including criminal records check) is required prior to beginning employment. Any offer of employment may be rescinded if the background check reveals disqualifying information, and/or it is discovered that the candidate knowingly withheld or falsified information. Failure to satisfactorily complete the background check may affect the continued employment of a current NAI employee who was conditionally offered the position.

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4 weeks ago

QA Sampler Raw Materials

Natural Alternatives International - Vista, CA 92081

Since 1980, NAI has been a leader in nutritional health, bringing whole food-based supplements to a global population. NAI is a leading expert and manufacturer of dietary supplements, and we are involved in every facet of the industry, including research, development, manufacturing, marketing, and advocacy. As a company, we continue to grow with manufacturing locations in Vista and Carlsbad, CA. We are looking for seasoned and entry level candidates that are interested in working for global company with opportunities for growth, development, competitive pay, and benefits. Summary The Quality Assurance Sampler is responsible for sampling Raw Material ingredients and assisting with incoming inspection functions, Essential Duties & Responsibilities Sampling of raw material ingredients using statistical sampling plans and aseptic technique Creating composite samples, pulling retention and test samples from the composites Verifying material quantities, NAI and Supplier lot # 's, Supplier/Manufacturers, and Kosher/Halal/Organic symbology on material containers as applicable Inspect material for damages and extraneous matter Checking for material uniformity, consistency, texture etc. from container to container Movement of material for sampling Quality Assurance communicates damages and non-conformances to QA Coordinator Daily cleaning of sampling tools, sampling table, hydraulic carts, and sampling hood Bi-Weekly sanitizing of sampling hoods, and hydraulic carts Understands and follows company procedures and policies for sampling materials in compliance with 21 CFR 111, Dietary Supplement cGMP Understands and follows written instructions provided in company procedures and specifications Able to communicate and interact effectively with Warehouse and Quality personnel Maintain a sanitary working environment Complete documentation as required Performs other jobs as requested Qualifications Education & Experience Minimum: High School Diploma or equivalent Strong communication skills and the ability to follow both written and verbal instructions Ability to document information completely and accurately Proven organizational skills and task management ability Physical Demands While performing the duties of this job, the employee is regularly required to walk; use hands to finger, handle, or feel; reach with hands and arms; stoop and kneel; talk and hear, The employee is frequently required to sit and stand Specific vision abilities required by this job include close vision, color vision, peripheral vision, depth perception, and the ability to adjust and focus Lifting requirement: Up to the maximum safety-recommended 50 pounds The physical demands are representative of those that must be met by employee to successfully perform the essential functions of this job. Reasonable accommodations may be made upon request to enable individuals with qualified disabilities to perform the essential functions of the job. Training Standard Operating Procedure training required upon initial new hire training, annually, and as SOP's are updated, annual HACCP/Food Safety and GMP training requirement with assessment Decision Making Employee will make decisions related to raw material uniformity and consistency, compliance to Kosher, Halal, and Organic symbology container requirements, material integrity, etc. Communication Employee must demonstrate strong communication skills both written and verbal. Employee will be required to communicate within QA and WHSE departments Results of Action Decisions from sampling inspection will assist in material disposition Equipment Used Sampling tools, pallet jack, scales, hydraulic carts Work Environment Production facility where exposed to computerized equipment, moving mechanical parts, forklifts, heavy pallets, moderate to loud noise level, and air-borne dust and powders. While working, will be required to wear various GMP gowning and personal protective equipment (e.g., clothing, hair net, face mask, gloves, goggles, etc.) Benefits: Medical plan options – Two HMO and one PPO Dental, vision, life insurance and other voluntary benefit options. 3 weeks’ vacation and 11 paid holidays 401K including company matching and profit sharing $1,000 Employee Referral Bonus Quarterly employee lunches, Employee of Month and other recognition programs Opportunities for advancement Comprehensive training Tuition Reimbursement and more! NAI is an Affirmative Action/Equal Opportunity Employer and will consider all applications without regards to race, sex, age, color, religion, national origin, intersectionality, veteran status, physical or mental disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. Upon this conditional offer of employment, a satisfactory completion of a background check (including criminal records check) with submission and passing a pre-employment post offer drug test is required prior to beginning employment. Any offer of employment may be rescinded if the background check reveals disqualifying information, and/or it is discovered that the candidate knowingly withheld or falsified information. Failure to satisfactorily complete the background check may affect the continued employment of a current NAI employee who was conditionally offered the position. Upon successful completion of the background check process, we will determine the date when your employment begins. NAI utilizes E-Verify to electronically verify employment eligibility.

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4 weeks ago

Senior Facilities Manager

Argonaut Manufacturing Services - Carlsbad, CA 92010

Corporate Overview Argonaut Manufacturing Services Inc. is a contract manufacturing organization (CMO) headquartered in Carlsbad, CA with over 100,000 square feet of manufacturing space across four locations. The company is dedicated to serving highly innovative companies in the biopharmaceutical and molecular diagnostics industries. Argonaut is a full service, cost-effective partner, providing complete solutions in the areas of formulation, filling and final kitting of reagents and consumables. Argonaut provides quality and regulatory expertise to assure the highest in quality manufacturing and supply chain excellence. Benefits and Pay Range At Argonaut Manufacturing Services we value our employees and are proud to offer a comprehensive benefits package designed to support your well-being and financial future. Eligible employees enjoy: Medical, Dental, and Vision Insurance Company-Paid Life Insurance (1x Annual Salary) Voluntary Life Insurance Options Short-Term and Long-Term Disability Insurance Flexible Spending Account (FSA)Health Savings Account (HSA) 401(k) Retirement Plan with Company Matching 14 Days of Paid Time Off (PTO) 10 Paid Holidays Annually The pay range for this position is $145,000 - $160,000 annually. Actual compensation will be based on factors such as location, skills, education, experience, and other relevant qualifications. Position Overview In this role the Senior Manager will lead the Facilities department to ensure that all GMP manufacturing facilities, utilities, and related equipment are maintained and operated in a state of control, ready for production. The Senior Manager possesses extensive knowledge of the operation and maintenance of biopharmaceutical manufacturing facilities, clean rooms, automated controls systems, boilers, chillers, water purification systems, HVAC, MEP, cold storage units, building management systems, emergency electrical generation systems, and other plant systems and utilities. The Senior Manager will also be involved in the planning and execution of the company's expansion plans including oversight of construction of new facilities and modifications of existing facilities. This role is an on-site position Monday - Friday 8 hours/day (excluding lunch break). Overtime, weekends and holidays will be required as needed. Flexible start time between 7:00 am - 9:00 am with a consistent schedule. Responsibilities and Duties Work closely with Facilities and Manufacturing Operations personnel to maximize manufacturing uptime by maintaining the facilities, utilities and equipment in a state of production readiness. Daily operational support and troubleshooting as needed. Serve as the Subject Matter Expert (SME) for a variety of facilities, utilities and equipment supporting a GMP biopharmaceutical and med device manufacturing operation. Oversee work performed by contractors to ensure compliance with company procedures, plans and regulatory requirements. Ensure project documents are complete, current, and stored appropriately. Track and analyze historical data of operations and KPIs. Provide reports and presentations on proposed continuous improvement projects. Provide input and oversee the creation of SOPs, Protocols, Deviations, CAPAs and other GMP documentation. Provide input on procedures for equipment maintenance and calibration. Support of engineering change control for new equipment design and modification. Creation of impact assessments for equipment changes. Support of internal processes to ensure regulatory compliance is maintained. Cross-functional collaboration to complete projects and solve problems. Requirement for excellent communication skills and the ability to interact with cross-functional groups at all levels. Ability to manage competing priorities and maintain tight timelines. Ability to work irregular hours, nights, weekends. Perform other duties as assigned. Requirements and Qualifications Work closely with Facilities and Manufacturing Operations personnel to maximize manufacturing uptime by maintaining the facilities, utilities and equipment in a state of production readiness. Daily operational support and troubleshooting as needed. Serve as the Subject Matter Expert (SME) for a variety of facilities, utilities and equipment supporting a GMP biopharmaceutical and med device manufacturing operation. Oversee work performed by contractors to ensure compliance with company procedures, plans and regulatory requirements. Ensure project documents are complete, current, and stored appropriately. Track and analyze historical data of operations and KPIs. Provide reports and presentations on proposed continuous improvement projects. Provide input and oversee the creation of SOPs, Protocols, Deviations, CAPAs and other GMP documentation. Provide input on procedures for equipment maintenance and calibration. Support of engineering change control for new equipment design and modification. Creation of impact assessments for equipment changes. Support of internal processes to ensure regulatory compliance is maintained. Cross-functional collaboration to complete projects and solve problems. Requirement for excellent communication skills and the ability to interact with cross-functional groups at all levels. Ability to manage competing priorities and maintain tight timelines. Ability to work irregular hours, nights, weekends. Perform other duties as assigned. Argonaut Manufacturing Services, Inc. is proud to be an equal opportunity employer committed to providing employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age or disability, or any other class protected by Federal, State or local laws. Argonaut complies will all employment eligibility verification requirements of the Immigration and Nationality Act and all must have the authorization to work in the US.

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4 weeks ago

Certified Welding Inspector

Senior - Oceanside, CA 92056

Company Description Who is Steico Industries? STEICO has made its name manufacturing precision tube and duct assemblies to the world's major airframe manufacturers. We manufacture tube and duct assemblies. We work with a wide variety of materials including aluminum, steel, titanium, and other alloys and produce parts of all complexities. STEICO holds accreditations with NADCAP and is certified to AS9100 and ISO14001. Our focus on responsiveness and continuous improvement regularly creates manufacturing innovation. STEICO is an integral part of our customers supply chains that include Boeing, Lockheed Martin, BAE, Northrop Grumman, Honeywell, Honda Aviation, and many others. About our parent company: Senior is an FTSE UK based international manufacturing Group with 26 operations in 12 countries. Senior designs, manufactures and markets high-technology components and systems for the principal original equipment producers in the worldwide aerospace, defense, and land vehicle and power & energy markets. We have a long history of well-respected brands and an excellent reputation in our key market sectors. Senior delivers value to its customers and shareholders via operational excellence that is underpinned by its people and processes. Senior’s experienced manpower support, effective use of raw material, and high technology enable it to deliver optimized components within a short development time and at most competitive prices. The Group is split into two divisions, Aerospace and Flexonics, servicing five key sectors. Our global values underpin what we do, and how we do it … Job Description AM Shift: Monday - Friday 7:00AM - 3:30PM Pay: $28.46 - $30.30 an hour depending on experience Safety – Integrity – Customer Focus – Respect & Trust – Accountability – Excellence As a Certified Weld Inspector you will: A certified welding inspector (CWI) is responsible for ensuring the quality of welding work through monitoring, testing, and inspecting welded materials for defects or imperfections. The CWI will work with welding and fabrication teams to ensure adherence to standards and specifications and may be responsible for overseeing the welding of specific projects or parts of projects. What will my responsibilities include? AWS CWI certification Inspect weldments to various code requirements: Conduct visual inspections of welding activities, including pre-weld inspections, in-process inspections, and post-weld inspections, to verify compliance with welding procedures, specifications, and applicable codes (e.g., ASME, API, AWS) Perform non-destructive testing (NDT) methods, such as ultrasonic testing (UT), magnetic particle testing (MT), liquid penetrant testing (PT), and radiographic testing (RT), to evaluate weld quality and detect defects Maintain detailed records of welding inspections, test results, and quality assurance activities Read and work to blueprints Dispatch daily work requirements – develop specific goals and plan Train, quality and certify new weld and fabrication personnel Ensure compliance to all Steico quality processes and procedures Diagnose and eliminate bottlenecks Support and provide guidance on customer welding approvals and Nadcap welding certifications Other reasonable duties as business and operational needs dictate Qualifications What key skills and experience do I need? Certified Weld Inspector and AWS Welding qualification and for Stainless, Inconel, Titanium and Aluminum Experience in welding (manual and orbital) and fabrication. High level of knowledge and experience in aerospace tube manufacturing including understanding of customer specifications Extensive knowledge of all manufacturing tools and equipment on the shop floor. Ability to read and interpret blueprint drawings Proficient using MS Suite including Excel, Word, PowerPoint, etc. Working knowledge of Microsoft programs; ability to utilize an ERP system to retrieve data as needed in the performance of his job Intermediate mathematics skills, including basic algebra Ability to clearly communicate technical data to all levels of the organization Must be able communicate and interact effectively with employees at all levels of the organization, both verbally and written Education and Experience: High School Diploma with 2+ years of experience OR equivalent education/experience in quality/inspection/welding/NDT/etc. Additional Information Why Join Steico Industries, Inc.? Joining Steico Industries, Inc. a company of Senior Plc. means not only a rewarding career with a tight-knit and collaborative team, but you will also enjoy a competitive compensation package that includes a market-led base salary and a comprehensive benefits package along with wellness benefits, employee recognition program, matching 401k plan, paid vacation, flexible hours, employee wellness activities, tuition reimbursement, and community involvement initiatives. Please understand that you will only be considered an applicant if you apply for a posted position directly through our Company website and meet the qualifications of the job. If you need a reasonable accommodation to apply, please contact the Steico Industries at 760-438-8015. Prior to an offer of employment, applicant employment references maybe requested. Trade Compliance Statement Access to our facilities is restricted under the International Traffic in Arms Regulations (ITAR) and/or the Export Administration Regulations (EAR) to U.S. Persons (U.S. Citizens, lawful permanent residents, U.S. Nationals, U.S. refugees, asylees, or temporary residents under amnesty provisions ), and to properly licensed foreign persons. Applicants receiving a conditional offer of employment will be required to provide information to determine whether they are subject to these regulations and, if so, to assess their country of chargeability for export control purposes. Additionally, potential employee names will be screened against the Consolidated Screening List (maintained by the United States government) to determine eligibility to receive controlled technical data. To ensure there is no unexpected delay to your start date with our Company and due to the potential need to obtain an export license, we would like to promptly assess whether such a license is needed to access our facility and/or systems. Such licenses can take several weeks/months to obtain from the U.S. Government. Our Trade Compliance department may reach out to you with a Licensing Assessment form, which we request you kindly complete and return as soon as possible. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. EOE M/F/D/V/VEVRAA Federal Contractor

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4 weeks ago

Manufacturing Manager

IPS Group, Inc - San Diego, CA 92121

Company: IPS Group, Inc. is a design, engineering and manufacturing company focused on low power wireless telecommunications and parking technologies. IPS manufactures its products locally and has been delivering world-class solutions to the telecommunications and parking industries for over 20 years. The company is best known for their patented credit card enabled, solar powered single-space parking meter and web-based management system. Job Description: The Manufacturing Manager is responsible for leading the IPS Manufacturing and Assembly in San Diego, CA. Responsibilities include management of the Manufacturing and Assembly, Staffing, and Equipment OEE. Additionally, this role will require collaboration with Supply Chain, Warehousing, Logistics, Quality Control/ Assurance, Engineering, Cost Accounting and Continuous Improvement. Job Duties: Manufacturing and Assembly Ensure all manufacturing operations operate in a safe manner. Lead production associates to achieve daily, weekly, and monthly production targets. Manage production capacity based on sales, inventory and operations planning. Generate and deliver production KPI reports. Maintain on time delivery of 100%. Manage workforce staffing. Quality Collaborate with QA/QC to develop and implement control plans for fabricated, assembled, and manufactured goods. Ensure manufactured products meet or exceed established quality standards. Assist Quality Assurance and Engineering to achieve in-process quality standard compliance. Validate product QC procedures and monitor for all finished goods. Perform regular quality audits on all finished goods, report findings and corrective actions. Inventory Management Collaborate with cost accounting and warehouse leadership to ensure accurate inventory. Assist IPS accounting team in reconciling variances. Perform on-site inventory audits / Physical inventory counts. Continuous Improvement Improve productivity by implementing Lean manufacturing. Review and change process and workflows to achieve manufacturing targets. Experience and Education: BS in Engineering or another related field. Experience with manufacturing safety guidelines and policies. Minimum 5+ years’ experience in manufacturing and operations leadership. Skills Provide leadership for the successful day-to-day operation of the facility. Strong hands-on user of MRP/ERP software and maintenance systems. Experience with forecasting and production planning systems. Strong computer skills including the ability to prepare spreadsheets and use Microsoft Office Products (Word, Excel, Power Point and/or Access) to analyze data trends. Deep understanding of quality standards and specifications for manufactured goods. Previous experience/best practices implementing and using continuous improvement/lean tools such as Six Sigma, 5-S, Lean Manufacturing, and Transactional Lean to drive improvement. Experience in budgeting/expense management with basic understanding of financial accounting practices. Demonstrated understanding of the principles and applications associated with manufacturing operations, maintenance, and engineering. Excellent interpersonal communication and listening ability. A strong ability to be adaptable and flexible. Strong analytical and decision-making skills. Physical Demands, Equipment and Machinery The work environment will be in an industrial setting with around machinery and equipment. The environment described here is representative of those that an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with qualified disabilities to perform the essential functions. The position is in the factory and could involve sitting, standing, walking and lifting and manipulating materials for long periods of time throughout the day. The environment is clean and typically free from dust and hazardous materials. This indoor environment is temperature controlled. Note: The above statements are not intended to be an exhaustive list of all responsibilities, duties and skills required of personnel in this classification. Nothing in the job description restricts IPS Group, Inc. from the right to change, assign, or reassign duties and responsibilities at any time for any reason. Furthermore, they do not establish a contract for employment as this is an “AT-Will employer. It is the policy of IPS Group, Inc. not to discriminate against any applicant for employment, or any employee because of age, color, sex, disability, national origin, race, religion, sexual orientation, or veteran status. Compensation / Benefits: Benefits: 401(k) 401(k) matching Dental insurance Health insurance Life insurance Paid time off Vision insurance Job Type: Full-time Pay: $90,000.00 - $140,000.00 per year An Equal Opportunity/Affirmative Action Employer—M/F/D/V

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4 weeks ago

3rd Shift – Production/Manufacturing Operators

CAPTEK Softgel International - Vista, CA 92081

Become part of a team that champions wellness worldwide. CAPTEK® Softgel International is a global leader in the development and production of high-quality nutraceutical supplements. As a contract manufacturer organization (CMO), we collaborate with innovators from some of the world’s most successful brands. 3rd Shift: 10:00 PM - 6:30 AM Become part of a team that champions wellness worldwide. CAPTEK® Softgel International is a global leader in the development and production of high-quality nutraceutical supplements. Machine Operators • Technicians • Packaging • Inspection • Janitorial CAPTEK® is ACCEPTING APPLICATIONS for Production and Manufacturing positions. Responsibilities Include: • Operating equipment to defined standards and product requirement goals • Supporting a safe working environment by adhering to all plant safety, policies and procedures, including wearing appropriate Preventative Protective Equipment (PPE) • Conducting required quality checks on products to ensure customer satisfaction • Extensive amounts of reading, writing, and documenting • Working up to 8 hours per day in a loud/noisy, powdery, sometimes smelly environment • Must be able to perform tasks such as lifting, walking, climbing, stooping, standing, pushing and/or pulling We will hire and train candidates who are self-motivated. We promote from within and offer excellent growth opportunities for anyone looking for a career not just a job. Benefits Include: • Medical Insurance • Dental Insurance • Vision Insurance • Life Insurance • Long Term Disability • $500 Referral Bonus Program • 401k • 401k Matching • Flexible Spending Account (FSA) • Employee Assistance Program (EAP) • Tuition Reimbursement We comply with E-Verify, Background Checks and Drug Screens. Thank you for your interest in joining the CAPTEK team. You will be contacted shortly if your application is selected.

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4 weeks ago

Director of QC

Abzena - San Diego, CA 92121

With extensive experience in developing biologics and bioconjugates, we offer a seamless service delivered by fully integrated teams, from early discovery to commercial manufacturing. Forward-thinking and committed, we find the best solution and use the right technologies to design, develop and manufacture your products to ensure we get vital medicines to patients quickly and safely. We are dedicated to quality excellence. We are driven to get better treatments to market, efficiently and responsibly by reducing timelines and delivering the highest quality products and services. We are Abzena. More than a CDMO, we are a responsible and dedicated partner that takes care of your products from concept to patient. The Director of Analytical Testing is responsible for the management of the QC Analytical Testing Laboratory and the QC Microbiology Laboratory including testing of all relative samples. The leader will be responsible for planning and scheduling of all tests and managing a team of analysts to conduct testing in a reproducible manner. The position requires an exceptional technical leader with a thorough understanding of analytical methodology, leadership attributes, critical thinking skills and problem solving, and outstanding team management skills. Responsibilities Provides strategic and scientific oversight to the Analytical Testing laboratory. Ensures the analytical control strategy is aligned with Abzena's sourcing strategy for products. Provides support to Operations and Quality staff in responding to client requests that require scientific and/or regulatory information. Operates as the primary contact to other departments such as Project Management, Manufacturing, and Quality Assurance relevant to project execution activities. Provides support to clients and operations staff in day-to-day operations to develop sound scientific and regulatory compliant solutions in the design, execution, and evaluations of studies, including addressing deviations and unexpected results. Participates in and prepares responses to both internal and external technical and quality assurance audits as required. Performs quality review and analysis of laboratory data, protocols, and reports. Supports quality in the development of short-range and long-range operating objectives, budget, organizational structure, staffing requirements, and succession plans. Ensures a continued information flow amongst other departments and external collaborators/partners. Represents Analytical testing strategies to regulatory authorities, clients, and inspections/audits. Contributes to development of an operating model and continuous improvement of platform methods. Demonstrates administrative leadership with knowledge-based expertise in related areas that can be applied to meeting Abzena's strategic goals. Contributes to Quality Control department goals and objectives. Operate to the highest ethical and moral standards. Comply with Abzena's policies and procedures. Communicate effectively with clients, supervisors, colleagues, and staff. Participate effectively as a team player in all aspects of Abzena's business. Adhere to quality standards set by regulations and Abzena policies, procedures, and mission. Perform other related duties as assigned. Qualifications PhD, MS or BS virology, biochemistry molecular biology or related disciplines, along with relevant experience 10 or more years of experience in the biotechnology, or pharmaceutical industry. Strong background in Quality Control Analytical Development and Quality Control experience with biologics development experience Demonstrated leadership ability in pharmaceutical manufacturing of biotechnology products, aseptic processing, analytical method development, technology transfer, method qualification/validation and process development. Experience in a cGMP environment and have a solid understanding of GMP. Excellent communication, interpersonal, organizational, writing, and managerial skills Regulatory agency interaction experience preferred. cGMP compliance training, method development, qualification, and validation experiences Strong organizational skills and attention to detail for composing and proving relevant documents, materials, scheduling, establishing priorities and meeting deadlines. FLSA: Abzena is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, and training.

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4 weeks ago

Labor/Fabricator/Fitter/Structural Steel

- Oceanside, CA 92054

Job Summary: The Structural Steel Labor assists fabricators, welders, and fitters in the daily operations of a structural steel fabrication shop. This position supports the preparation, assembly, and finishing of steel components, ensuring that all materials are handled safely and efficiently to meet production schedules and quality standards. Key Responsibilities: * Assist in moving, positioning, and organizing steel materials and components. * Help fabricators with cutting, grinding, drilling, and cleaning steel parts. * Operate basic power tools and hand tools safely under supervision. * Support welders by preparing materials, cleaning welds, and handling parts. * Maintain a clean and organized work area, including sweeping, sorting scrap, and disposing of debris. * Load and unload materials from trucks using forklifts, cranes, or hoists (training provided). * Perform basic measurements, marking, and layout tasks under supervision. * Follow all shop safety rules, including wearing required personal protective equipment (PPE). * Assist in minor maintenance of equipment and tools as directed. * Perform other related duties as assigned by the shop foreman or supervisor. Qualifications: * Previous experience in construction, metal work, or manufacturing is an asset but not required. * Driver license * Some welding experience * Ability to read a tape measure and basic hand tools. * Physically able to lift 50+ lbs and work on feet for extended periods. * Willingness to learn and follow instructions carefully. * Dependable, punctual, and safety-oriented. Work Environment: * Indoor and outdoor fabrication shop with exposure to noise, dust, heat, and heavy materials. * Must wear safety boots, gloves, eye protection, and other PPE as required. Schedule & Compensation: * , Monday–Friday, 6:30 a.m.–3:00 p.m. * $24–$29/hr depending on experience Job Type: Full-time Pay: $24.32 - $29.28 per hour Work Location: In person

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4 weeks ago

Cabinet Vision Engineer

Trosak Cabinets - San Marcos, CA 92078

*Responsibilities* * Create detailed cabinet models and shop drawings in *Cabinet Vision* * Generate cut lists, materials, and work orders for the shop * Review architectural drawings and design intent for accuracy * Handle redlines and revisions with efficiency and attention to detail * Collaborate with project management to resolve RFIs and layout questions * Maintain organized digital files and clean drawing standards *Qualifications* * *2–4 years of Cabinet Vision experience* (custom cabinetry or millwork environment preferred) * Solid understanding of cabinet construction methods and joinery * Ability to read and interpret architectural plans * Strong attention to detail and commitment to accuracy * Reliable, organized, and comfortable working under deadlines * Basic proficiency with Microsoft Office *Compensation & Benefits* * *$28 – $35/per hour DOE* * Full-time, steady work schedule (7:00 AM – 3:30 PM typical) * 90-day review with potential for performance-based raise * Supportive, small-team environment where your work directly impacts production Stable, family-run company focused on quality and customer satisfaction Job Type: Full-time Pay: $28.00 - $35.00 per hour Expected hours: 40 per week Benefits: * Health insurance * Paid time off Work Location: In person

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4 weeks ago

Sr. Specialist, Continuous Improvement

L3Harris - San Diego, CA 92121

L3Harris is dedicated to recruiting and developing high-performing talent who are passionate about what they do. Our employees are unified in a shared dedication to our customers’ mission and quest for professional growth. L3Harris provides an inclusive, engaging environment designed to empower employees and promote work-life success. Fundamental to our culture is an unwavering focus on values, dedication to our communities, and commitment to excellence in everything we do. L3Harris Technologies is the Trusted Disruptor in the defense industry. With customers’ mission-critical needs always in mind, our employees deliver end-to-end technology solutions connecting the space, air, land, sea and cyber domains in the interest of national security. Job Title: Sr. Specialist Continuous Improvement Job Code: 29510 Job Location: San Diego, CA Summary: As a Senior Specialist in Continuous Improvement, you will leverage your deep expertise in Lean and Six Sigma methodologies, along with your comprehensive project management skills, to lead and oversee complex projects aimed at enhancing operational excellence. Collaborating extensively within and across functions to secure cooperation on key operational processes, practices, and procedures. Through your initiatives, you will drive substantial improvements to systems and processes, recommending and implementing enhancements that optimize efficiency and effectiveness. Your efforts will be instrumental in achieving operational targets for specific programs and projects, resulting in a significant positive impact on departmental outcomes. Job Description: Utilizes Lean/Six Sigma Tools: Apply Lean/Six Sigma methodologies and tools to support strategic deployment and achieve established Operational Excellence objectives. Operates with General Oversight: Manage tasks and projects with general supervision, demonstrating a high degree of autonomy and accountability in driving continuous improvement efforts. Facilitates Effective Communication: Engage in clear and effective communication within the team and across departments to convey and interpret information, fostering collaboration and alignment. Contributes to Process Enhancements: Actively participate in identifying, recommending, and implementing changes to systems and processes that enhance efficiency and effectiveness in work routines. Drives Operational Success: Strive to achieve operational targets that directly impact team performance and contribute to the overall success of departmental results. Essential Functions: Strategic Application of Lean/Six-Sigma Tools: Employ Lean/Six-Sigma methodologies to support strategic deployment and accomplish Operational Excellence goals. Operate with General Supervision: Perform duties under general supervision, demonstrate increasing autonomy and reduced need for guidance as proficiency grows. Provide Coaching and Training: Offer guidance, coaching, and training to other employees, fostering a culture of continuous improvement and teamwork. Manage Complex Projects: Oversee and manage complex projects, including delegating tasks, reviewing work products, and ensuring project milestones are met. Facilitate Effective Communication: Communicate effectively within and outside the department, occasionally interfacing with external stakeholders such as customers and vendors. Clearly explain and interpret processes and procedures to various audiences. Drive Process Enhancements: Identify and implement substantial improvements to systems and processes to enhance job area performance and drive operational excellence. Innovative Problem Solving: Engage in comprehensive information gathering, analysis, and investigation to solve complex problems and foster innovative solutions. Draw from prior experience and in-depth analysis to address multifaceted issues. Apply Discretion and Judgment: Exercise discretion within established boundaries and procedures to make informed decisions and propose viable solutions for review. Impact Departmental Success: Work towards achieving operational targets with direct influence on departmental outcomes. Contribute to the development of departmental goals and assist in planning efforts Qualifications: Bachelor’s Degree and minimum 6 years of prior relevant experience. Graduate Degree and a minimum of 4 years of prior related experience. In lieu of a degree, minimum of 10 years of prior related experience. Preferred Additional Skills: Industrial Engineering. Lean, Six-Sigma certification. Excellent communication, technical writing and presentation skills Project management. Proficient in MS Office suite, Visio, etc. In compliance with pay transparency requirements, the salary range for this role in California is $86,500 - $160,500. This is not a guarantee of compensation or salary, as final offer amount may vary based on factors including but not limited to experience and geographic location. L3Harris also offers a variety of benefits, including health and disability insurance, 401(k) match, flexible spending accounts, EAP, education assistance, parental leave, paid time off, and company-paid holidays. The specific programs and options available to an employee may vary depending on date of hire, schedule type, and the applicability of collective bargaining agreement #LI-SS1 L3Harris Technologies is proud to be an Equal Opportunity Employer. L3Harris is committed to treating all employees and applicants for employment with respect and dignity and maintaining a workplace that is free from unlawful discrimination. All applicants will be considered for employment without regard to race, color, religion, age, national origin, ancestry, ethnicity, gender (including pregnancy, childbirth, breastfeeding or other related medical conditions), gender identity, gender expression, sexual orientation, marital status, veteran status, disability, genetic information, citizenship status, characteristic or membership in any other group protected by federal, state or local laws. L3Harris maintains a drug-free workplace and performs pre-employment substance abuse testing and background checks, where permitted by law. Please be aware many of our positions require the ability to obtain a security clearance. Security clearances may only be granted to U.S. citizens. In addition, applicants who accept a conditional offer of employment may be subject to government security investigation(s) and must meet eligibility requirements for access to classified information. By submitting your resume for this position, you understand and agree that L3Harris Technologies may share your resume, as well as any other related personal information or documentation you provide, with its subsidiaries and affiliated companies for the purpose of considering you for other available positions. L3Harris Technologies is an E-Verify Employer. Please click here for the E-Verify Poster in English or Spanish. For information regarding your Right To Work, please click here for English or Spanish.

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