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Job Summary: We are looking for a skilled injection molding Machine Operator. A great machine operator is reliable and able to work with attention to detail and safety standards. On-the-job training is a good way to discover how to do the job better, so you should have willingness to learn and improve. Being a team player is essential since all tasks will require close collaboration with co-workers. The goal will be to ensure that production procedures will be carried on smoothly to maximize efficiency and profits. Schedule: Monday-Friday 7:00am-2:30pm. All weekends and major holidays off. Essential Functions: Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. · Will be responsible for removal and QC the injection molded parts from the Injection molding machines, trim/package/case the parts that pass QC. · Will be responsible for running up to 2 machines at a time or multiple tasks operating 1 machine and completing secondary packaging · Will work with basic hand tools such as cutter/razor blade to remove excess plastic form insoles inspecting and trimming parts before packaging in boxes. · Will assist in other areas as needed Job Specifications: · Proven experience as a machine operator · Understanding of production procedures · Adherence to health and safety regulations (e.g. constant use of protective gear) · Ability to stand and work in a fast-paced environment for 8 or more hours · Analytical skills · Attention to detail · Teamwork and communication skills · Physical stamina and strength · High school diploma or equivalent; technical degree is a plus Supervisory Responsibility: None. Work Environment: This job operates in a warehouse manufacturing environment. This role routinely uses injection molding machines. Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. · Candidate should be able to work on-site, on scheduled days · Physical need to bend, twist, squat, occasionally climb up and down ladders, and lift up to 25 lbs. While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to sit at a computer workstation and work for prolonged periods; stand; walk; use hands to finger, handle or feel; and reach with hands and arms. Position Type: This is a full-time position. Occasional evening and weekend work may be offered/required as job duties demand. Requirements: Additional Eligibility Qualifications None required for this position. AAP/EEO Statement MPR Brands (Dr.'s Own, LLC) is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status or any other characteristic protected by law. Other Duties Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice. Pay: $18-19.50/hr Brand: Dr.'s Own, LLC
Date Posted: 2026-02-05 Country: United States of America Location: US-CA-CARLSBAD-582 ~ 2752 Loker Ave W ~ LOKER Position Role Type: Onsite U.S. Citizen, U.S. Person, or Immigration Status Requirements: This job requires a U.S. Person. A U.S. Person is a lawful permanent resident as defined in 8 U.S.C. 1101(a)(20) or who is a protected individual as defined by 8 U.S.C. 1324b(a)(3). U.S. citizens, U.S. nationals, U.S. permanent residents, or individuals granted refugee or asylee status in the U.S. are considered U.S. persons. For a complete definition of “U.S. Person” go here: https://www.ecfr.gov/current/title-22/chapter-I/subchapter-M/part-120/subpart-C/section-120.62 Security Clearance Type: None/Not Required Security Clearance Status: Not Required Join a dynamic, fast-moving team in beautiful Carlsbad, California, where innovation meets ocean breezes! As a Test Technician, you’ll be at the heart of cutting-edge product development—powering breakthroughs by ensuring every component performs flawlessly. In this hands-on role, you’ll dive into electrical and mechanical testing, troubleshoot complex systems, and collaborate closely with engineers to bring next-generation technology to life. If you thrive on solving puzzles, love working with precision equipment, and get energized by the idea of transforming bold ideas into real-world performance, this role puts you right where the action is. Expect variety, challenge, and the satisfaction of knowing your expertise directly shapes products used around the world. Bring your curiosity, your technical skill, and your passion for excellence—Carlsbad is waiting for you. What You Will Do Set up & operate a variety of test equipment Test a variety of electronic units using prescribed test procedures Configure and/or verify regular test equipment to fit special tests Perform complex technical tasks in a wide variety, or specialized areas, requiring advanced skills and developed expertise in electronic test to the component level of avionics equipment in accordance with approved drawings, specifications and procedures. Expert at the application of electronic theory to test, troubleshoot, determine solutions applicable to the area/product/ or program charter. Identify problems, identify solutions and effectively implement corrective action. Perform product testing as directed. Use precision measuring equipment, read detailed mechanical drawings and be able to interpret specifications and requirements. Troubleshoot, diagnose, and identify calibration and equipment problems. Highly proficient at test data analysis. Inspect/verify materials/parts and sub-assemblies to ensure proper identification, configuration, segregation and quality status. Subject matter expert on technical issues and should be able to fill in for any absent technician. Write technical and/or administrative reports as required. Assist Technicians and/or Engineers in defining, analyzing, and solving problems. Provide support as needed for lean events and Total Productive Maintenance activities. Mentor less experienced technicians to achieve established objectives. Perform as member of a team utilizing effective communication skills. Actively promotes team decision making. Directly interface with responsible personnel from various departments on technical matters related to specific problems/issues. Flexibility to support production schedule requiring working overtime hours and alternate shift hours. Physical Demands: Transport product with or without product carts; lift up to 25 pounds unassisted; sit at workbench/test stands for extended periods of time; stand at workbench/test stands for extended periods of time; bend, stoop, reach, turn as required; use hands for extended periods of time to perform test & troubleshooting tasks; distinguish colors and meet vision requirements. Qualifications You Must Have Typically requires HS diploma (or equivalent, e.g. G.E.D in the US) or vocational/technical education in related discipline with a minimum of 2 years of relevant experience. Qualifications We Prefer 2+ years direct experience in electronic test and troubleshooting Understand theory of electronic circuitry & electrical components Proficient in reading and interpreting assembly / test instructions, engineering standards, engineering prints, and schematics. Ability to understand and operate electronic test equipment. Some of our competitive benefits package includes: Medical, dental, and vision insurance Three weeks of vacation for newly hired employees Generous 401(k) plan that includes employer matching funds and separate employer retirement contribution, including a Lifetime Income Strategy option Tuition reimbursement Life insurance and disability coverage Optional coverages you can buy: Pet Insurance, Home and Auto, additional life insurance, accident insurance, critical illness insurance, group legal Ovia Health, fertility and family planning Employee Assistance Plan, including up to 5 free counseling sessions Redbrick - Incentives for a Healthy You Autism Benefit Doctor on Demand, virtual doctor visits Adoption Assistance Best Doctors, second opinion program And more! Do you want to be a part of something bigger? A team whose impact stretches across the world, and even beyond? At Collins Aerospace, our Mission Systems team helps civilian, military and government customers complete their most complex missions — whatever and wherever they may be. Our customers depend on us for intelligent and secure communications, missionized systems for specialized aircraft and spacecraft and collaborative space solutions. By joining our team, you’ll have your own critical part to play in ensuring our customer succeeds today while anticipating their needs for tomorrow. Are you up for the challenge? Join our mission today. *Please ensure the role type (defined below) is appropriate for your needs before applying to this role. Onsite: Employees who are working in Onsite roles will work primarily onsite. This includes all production and maintenance employees, as they are essential to the development of our products. The salary range for this role is 46,592 USD – 87,386 USD. The salary range provided is a good faith estimate representative of all experience levels. RTX considers several factors when extending an offer, including but not limited to, the role, function and associated responsibilities, a candidate’s work experience, location, education/training, and key skills. At Collins, the paths we pave together lead to limitless possibility. And the bonds we form – with our customers and with each other - propel us all higher, again and again. Apply now and be part of the team that’s redefining aerospace, every day. As part of our commitment to maintaining a secure hiring process, candidates may be asked to attend select steps of the interview process in-person at one of our office locations, regardless of whether the role is designated as on-site, hybrid or remote. Hired applicants may be eligible for benefits, including but not limited to, medical, dental, vision, life insurance, short-term disability, long-term disability, 401(k) match, flexible spending accounts, flexible work schedules, employee assistance program, Employee Scholar Program, parental leave, paid time off, and holidays. Specific benefits are dependent upon the specific business unit as well as whether or not the position is covered by a collective-bargaining agreement. Hired applicants may be eligible for annual short-term and/or long-term incentive compensation programs depending on the level of the position and whether or not it is covered by a collective-bargaining agreement. Payments under these annual programs are not guaranteed and are dependent upon a variety of factors including, but not limited to, individual performance, business unit performance, and/or the company’s performance. This role is a U.S.-based role. If the successful candidate resides in a U.S. territory, the appropriate pay structure and benefits will apply. RTX anticipates the application window closing approximately 40 days from the date the notice was posted. However, factors such as candidate flow and business necessity may require RTX to shorten or extend the application window. RTX is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability or veteran status, or any other applicable state or federal protected class. RTX provides affirmative action in employment for qualified Individuals with a Disability and Protected Veterans in compliance with Section 503 of the Rehabilitation Act and the Vietnam Era Veterans’ Readjustment Assistance Act. Privacy Policy and Terms: Click on this link to read the Policy and Terms
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. Summary: It is the responsibility of the QA Lead to assist and support the QA Supervisor in the oversight of QA activities and training of new hires. Essential Duties and Responsibilities: • The QA Lead is responsible for the supervision of QA Technicians. • Assist QA management in providing direction, assigning tasks, and training. • Assist in training new inspectors on proper documentation and inspection techniques. • Assist in training of plant personnel in GMPs. • Monitor HACCP and Food Safety adherence. • Assist management in creating quality plans and procedures. • Assist with quality decisions with respect to product non-conformances. • Recommend corrective actions for quality issues. • Assist in preparation for customer and regulatory inspections. • Perform and document a wide variety of inspections, checks, tests, and/or sampling procedures. • Monitor all aspects of the manufacturing operations and report non-conformances to the supervisor. • Assist management in conducting inquiries and investigations. • Review documentation to assure accuracy and completeness, and to prevent errors. • Perform reconciliation and closing of batch records both in hard copy and electronic systems. • Ensure timely release of finished goods. • Maintain quality records, reports, logs, etc. • Disposition of products in the absence of Supervisor. • Perform other related duties as assigned by management. Qualifications: • Minimum of 4 years of relevant work experience with 2 years in a Lead role. • Competencies: • Good verbal and written communication • Good interpersonal skills • Ability to work independently and in a team environment • Ability to follow instructions • Good attendance and punctuality • Excellent Organization skills/ attention to detail/ ability to work effectively in a fast-paced environment Education/Experience: • Education: Minimum High School Diploma or equivalent. • Working knowledge of cGMPs and FDA regulations • General proficiency in using Microsoft Word, Excel, Outlook, and PowerPoint Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is occasionally exposed to work near moving mechanical parts; fumes, or airborne particles and risk of electrical shock. The noise level in the work environment is usually moderate. Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include Close vision, Peripheral vision, and the ability to adjust focus. While performing the duties of this job, the employee is occasionally required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl and talk or hear. EEOC Statement: CAPTEK is an equal employment opportunity employer. In order to provide equal opportunities to all individuals, employment decisions will be based on merit, qualifications, and abilities, not on any mental or physical disability. We comply with the law regarding reasonable accommodation for disabled employees and applicants. We do not discriminate on the basis of actual or perceived race, color, national origin, ancestry, sex (which includes pregnancy, childbirth, breastfeeding and medical conditions related to pregnancy, childbirth or breastfeeding), reproductive health decisions, gender, gender identity, gender expression, religious creed, disability (mental and physical) including HIV and AIDS, medical condition (cancer and genetic characteristics ), genetic information, age, marital status, sexual orientation, military and veteran status, or any other characteristic protected by federal, state or local law. Our management team is dedicated to this policy with respect to recruitment, hiring, placement, promotion, transfer, training, compensation, benefits, employee activities and general treatment during employment. Thank you for your interest in joining the CAPTEK team. You will be contacted shortly if your application is selected. Pay: $24.00 - $25.00 per hour Expected hours: 40 per week Benefits: * 401(k) * 401(k) matching * Dental insurance * Employee assistance program * Health insurance * Health savings account * Life insurance * Paid time off * Professional development assistance * Referral program * Tuition reimbursement * Vision insurance Work Location: In person
Quality Assurance Inspector I Monday – Friday, 12pm- 8:30pm The Quality Assurance Inspector I plays a pivotal role in ensuring the quality and integrity of Argen products. This position is responsible for inspecting in-process and finished goods within manufacturing areas to ensure compliance with ISO 13485:2016, FDA regulations, customer specifications, Argen requirements, and applicable procedures. Essential Duties and Responsibilities Conduct in-process and final inspections and testing as required. Perform visual inspections of finished products. Participate in internal assessments and audits. Maintain accurate inspection and test records. Identify and properly label non-conforming materials. Communicate product/material acceptability to production personnel. Assist with technical problem-solving and special projects. Maintain lot traceability, log sheets, and housekeeping standards. Follow safety policies and regulations to ensure safe work practices. Ensure lab cleanliness and safety standards are upheld. Perform thorough inspections during and after production to ensure quality and compliance. Verify product labeling for accuracy and regulatory compliance. Clear and prepare production lines for subsequent runs. Review and validate Device History Records (DHRs) for completeness and compliance. Perform other duties as assigned. Experience & Qualifications High school diploma or equivalent required. Experience in a GMP-regulated facility is a plus. Completion of 8 hours of Quality Training (PTC) required. Strong attention to detail. Proficiency in basic arithmetic and problem-solving. Understanding of raw materials, production processes, and quality control. Familiarity with administrative procedures and computer systems. Effective written and verbal communication skills. Ability to interpret technical drawings, artwork, and procedures. Commitment to safety and quality standards. Ability to follow site protocols, policies, and procedures. Flexible, motivated, and capable of working independently. Strong organizational and time-management skills. Problem-solving abilities. Ability to learn technical concepts through documentation and training. Preferred knowledge of regulatory standards including: cGMP ISO 13485 21 CFR Part 820 CMDR SOR/98-282 93/42/EEC RDC 16/2013 MHLW MO 169 TG(MD)R Sch3 Monday – Friday, 12pm- 8:30pm
SUMMARY: Assembles bouquets according to recipe specifications and maintains a clean and organized work area. Ensure finished product meets construction, quantity and quality specifications provided by Table Lead. ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned. Ensure the correct recipe is being used. Assemble Combos/Bunches by placing flowers on conveyor according to recipe specifications. Assemble Combos/Bunches by hand according to recipe specifications. Place bouquets in sleeve according to recipe specifications. Place rubber band and floral wrap on the finished product. Unpacks flower bunches from boxes. Removes sleeves from bunches and replaces with new sleeve and UPC label. Ensure and place greeting card and floral preservative food correctly. Verify UPC label has correct information. Check bouquet quality. Count and place throw away by stem in appropriate container. Separate green debris and place all waste in appropriate containers. Maintain work area clean and organized. Must be able to meet productivity goals set by Production Manager. Other duties as assigned. QUALIFICATIONS To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Ability to work on weekends and holidays. Ability to work in a refrigerated environment 45 degrees. Ability to lift to 10lbs. Ability to follow directions. Ability to communicate effectively. Ability to work effectively and relate well with others. EDUCATION and/or EXPERIENCE Six months work related experience or training; High School preferred. LANGUAGE SKILLS Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively before groups of customers or employees of an organization. Ability to converse in Spanish. MATHEMATICAL SKILLS Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret bar graphs. REASONING ABILITY Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Ability to deal with problems involving several concrete variables in standardized situations. PHYSICAL DEMANDS The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this Job, the employee is required to frequently stand, walk, use hands to finger, handle, or feel and talk and hear, and to reach with hands and arms. The employee must frequently lift and/or move up to 10 pounds and occasionally up to 10 lbs. Specific vision abilities required by this job include close vision, distance vision, color vision and ability to adjust focus. WORK ENVIRONMENT The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this Job, the employee is regularly exposed to extreme cold, wet, and humid conditions (non-weather). Work near moving mechanical parts. The noise level in the work environment is usually moderate.
SUMMARY: Assembles bouquets according to recipe specifications and maintains a clean and organized work area. Ensure finished product meets construction, quantity and quality specifications provided by Table Lead. ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned. Ensure the correct recipe is being used. Assemble Combos/Bunches by placing flowers on conveyor according to recipe specifications. Assemble Combos/Bunches by hand according to recipe specifications. Place bouquets in sleeve according to recipe specifications. Place rubber band and floral wrap on the finished product. Unpacks flower bunches from boxes. Removes sleeves from bunches and replaces with new sleeve and UPC label. Ensure and place greeting card and floral preservative food correctly. Verify UPC label has correct information. Check bouquet quality. Count and place throw away by stem in appropriate container. Separate green debris and place all waste in appropriate containers. Maintain work area clean and organized. Must be able to meet productivity goals set by Production Manager. Other duties as assigned. QUALIFICATIONS To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Ability to work on weekends and holidays. Ability to work in a refrigerated environment 45 degrees. Ability to lift to 10lbs. Ability to follow directions. Ability to communicate effectively. Ability to work effectively and relate well with others. EDUCATION and/or EXPERIENCE Six months work related experience or training; High School preferred. LANGUAGE SKILLS Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively before groups of customers or employees of an organization. Ability to converse in Spanish. MATHEMATICAL SKILLS Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret bar graphs. REASONING ABILITY Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Ability to deal with problems involving several concrete variables in standardized situations. PHYSICAL DEMANDS The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this Job, the employee is required to frequently stand, walk, use hands to finger, handle, or feel and talk and hear, and to reach with hands and arms. The employee must frequently lift and/or move up to 10 pounds and occasionally up to 10 lbs. Specific vision abilities required by this job include close vision, distance vision, color vision and ability to adjust focus. WORK ENVIRONMENT The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this Job, the employee is regularly exposed to extreme cold, wet, and humid conditions (non-weather). Work near moving mechanical parts. The noise level in the work environment is usually moderate.
San Diego, CAManufacturing – Manufacturing /Full Time /On-Site 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 Manufacturing Manager / Senior Manager will primarily be responsible for overseeing all Downstream/Upstream operations and performance manage a team of associates by means of training, mentoring and coaching. Responsibilities Manage a Downstream/Upstream shift team for top performance by providing technical, tactical and professional guidance. Schedule, plan, coordinate and support production activities. Perform frequent Gemba walks to identify the technical, procedural and equipment issues that hinder production and compliance and to enforce cleanroom standards for cleanliness and order. Monitor processes and results and troubleshoot issues as they arise to ensure process success. Communicate with associates and cross-functional teams, as appropriate, to assure prompt resolution to problems. Use professional concepts in accordance with company objectives to solve complex problems in creative and effective ways. Lead and guide associates through process and workflow improvement initiatives. Lead batch readiness activities such as general planning and coordination, material requests and transfer, and material and equipment staging. Direct floor operations for multiple projects simultaneously Remain responsible for operational performance and improvement of key metrics including safety, quality, delivery, cost, and morale. Provide hands-on training by guiding Downstream staff through operations to ensure compliance with training on all activities prior to GMP execution. Facilitate team cross-training opportunities for various tasks including autoclaving of assemblies, formulation of media and buffers, and Upstream operations to support overall success of the Biologics group. Perform annual and semi-annual reviews and track performance to provide associates with career growth and development opportunities. Conduct interviews and hire personnel to achieve staffing objectives. Assist with technical and compliance investigations, inspections, and audits. Represent departmental activities as needed, including project teams and task forces. Communicate effectively with clients, supervisors, colleagues, and staff and provide status of floor operation to leadership on a regular basis. Manage the timely review of GMP records for completeness, accuracy, and compliance in conformance with regulatory requirements. Draft, revise, and review manufacturing SOPs, master batch records, specifications, and other applicable cGMP documentation, as needed. Prepare technical reports, batch summaries and protocols. Adhere to quality standards set by regulations and Abzena policies, procedures, and mission. Operate to the highest ethical and moral standards. Adjust to a flexible work schedule including off-shift work, as needed. Perform additional duties as assigned. Qualifications BS in biotechnology, or a 4-year technical degree in related discipline. 8+ years experience in bio-manufacturing management, preferably in a process-oriented operation, or experience managing a major segment of a large manufacturer. Demonstrate knowledge and understanding of cGMPs and how they apply to responsibilities. Knowledge of purification using column chromatography Experienced with using single-use technologies Experience interacting with regulatory agencies. Computer proficiency, with the ability to present metrics/data. A proven ability to confidently compute basic arithmetic operations. $100,000 - $150,000 a year FLSA: Non-Exempt 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.
Summary About this role: Help reimagine cancer care by shaping how our Radioligand Therapies (RLT) reach more patients—safely, reliably, and faster. At Novartis, we’re pioneering the future of treatment through the fusion of nuclear medicine and precision oncology. Our QA Operations Specialist manages Quality aspects and projects within area of responsibility as well as ensuring and supporting overall GxP conformity and Compliance with the Novartis Quality Management Systems for the Indianapolis manufacturing site. Location: Carlsbad, CA #LI-Onsite Shift: This position involves shift work which will be defined through site start up and commercialization readiness. 12-hour shifts and weekends will be required. About the Role Key Responsibilities: Provide QA support of production, QC, engineering, and supply chain operations through review/approval of test records for batch release, SOPs, CAPAs, Deviations, OOX investigations, Quality Risk Assessments, Quality Plans/Events, protocols, and change controls. Additionally, provide shop floor oversight with QA/compliance guidance to support decision-making throughout these processes. Manufacturing support includes live batch record review and execution of AQL inspections. Support continuous quality improvement initiatives for manufacturing operations by collaborating with production, QC, engineering, and supply chain teams to implement and optimize processes that enhance efficiency. Support all regulatory inspections by assisting with preparedness initiatives and executing inspection activities, while also continuously performing/supporting any tasks necessary to ensure product quality and maintain site cGMP compliance as needed. Provide cGMP and associated OJT training to any other quality members and other operational areas as needed. Cross Train Expectations: QA Batch Release: Perform Master Batch Record approvals and issuance of batch records and labels Perform Raw Materials release, updating statuses of materials in the ERP system. Reviewing and approving raw material documentation and supplier CoAs to ensure quality and compliance of raw materials to be used in manufacturing processes. Perform Final Batch Record Review and Final Product Release Perform a comprehensive review of all executed batch records and associated documentation to ensure compliance with specifications and regulatory requirements before product release. QA Compliance Support the following programs as needed: Change Control Management, Customer Complaint Management, Document Control Management, Training Program Management, Supplier Qualification Program, Audit/Self-Inspection Program, Annual Product Quality Review (APQR), Logbook Issuance Essential Requirements Education: Bachelors' Degree, preferably in Life Sciences, Chemistry or related relevant degree strongly preferred. 3+ years of experience in a GxP (Bio)pharmaceutical or API manufacturing operations 2+ years of experience in a quality assurance role Collaborating across boundaries Functional Breadth QA and/or QC experience in pharmaceutical industry with environmental monitoring & cleanliness zones Knowledge of FDA and EU regulations and experience in US and international regulatory agency inspections. The salary for this position is expected to range between $89,600 and $166,400/year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves. Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Benefits and Rewards: Learn about all the ways we’ll help you thrive personally and professionally. Read our handbook (PDF 30 MB) EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accessibility & Reasonable Accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [email protected] or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message. Division Operations Business Unit Production / Manufacturing Location USA State California Site Carlsbad Company / Legal Entity U469 (FCRS = US469) AAA USA Inc. Functional Area Quality Job Type Full time Employment Type Regular Shift Work No VIDEO
At Valley Metals, LLC., a division of AeroFlow Technologies, we specialize in creating complex tube and duct assemblies using high-performance materials capable of withstanding extreme pressure, temperature, and chemical interactions. You can even find our products aboard NASA’s Space Launch System and in the F-35 fighter jets. That’s the level of quality and innovation you’ll be part of when you join our team. We are seeking a Production Scheduler to coordinate production and scheduling activities at our Poway, CA facility. This role is a hands-on position where you will be working closely with the production department as well as shipping and receiving functions to ensure on-time delivery, material availability, and operational efficiency. This is a critical role that partners closely with Operations, Procurement, Engineering, Quality and Customer-facing teams in a regulated aerospace manufacturing environment. So, what will you be doing as a Production Scheduler? Track orders throughout the various production operations. Package, un-package, and track parts going to and from outside vendors, may be required to pick up and deliver parts as schedules dictate. Monitor daily performance against schedule and drive recovery actions as needed. Drive continuous improvement in schedule adherence, on-time delivery, and planning accuracy. Ensure compliance with aerospace quality standards, customer requirements, and internal controls. To be successful in this role, you’ll need: Demonstrated experience owning facility-wide scheduling, or manufacturing planning. High level of attention to detail and numerically oriented. Excellent responsiveness and customer focus. Proficient in Microsoft Office software programs. Strong analytical skills and solutions-oriented mindset. Experience in aerospace manufacturing preferred. Self-starter with ability to multi-task and prioritize workday/projects independently. Excellent interpersonal and communication skills. Minimum 4 years of experience; preferably in aerospace manufacturing. Bachelor’s degree in Operations, Supply Chain, Engineering, or related field; equivalent experience considered. Salary Range: $65,000 to $75,000 annually (based on experience) Work Schedule: Monday - Friday, 6:30 am to 3:00 pm Reasons You’ll Love It Here We offer a full suite of employee benefits such as medical, dental, and vision insurance; as well as paid vacation, paid personal time, and various opportunities to give back to your local community. We also strongly encourage and provide opportunities for learning and professional development. Our Learning & Development team has put together in-house training on subjects like front-line supervisor essentials, how to manage conflict in the workplace, and many others. What to Do Next Now that you’ve had a chance to learn more about us, what are you waiting for! Apply today and allow us the opportunity to learn more about you and the value you can bring to our team. Once you apply, be sure to create a profile, and sign up for job alerts, so you can be the first to know when new opportunities become available. Our Commitment to You We’re proud of the fact that we are strongly rooted in being an inclusive, people-focused organization. Our company culture reflects values like integrity, ownership, and authenticity. We take these to heart, and if you do as well, you’ll fit right in. AeroFlow Technologies is committed to the full inclusion of all qualified individuals. In keeping with our commitment, AeroFlow Technologies will take the steps to assure that people with disabilities are provided reasonable accommodations. Equal Employment Opportunity/Affirmative Action/Veteran/Disability Employer For specific regional privacy notices please refer to our Privacy Policy.
About Carlsmed Our mission is to improve outcomes and decrease the cost of healthcare for spine surgery. The Carlsmed aprevo® personalized surgery platform is designed to improve the standard of care for spine surgery one patient at a time. Position Description As a Sr. Manufacturing Engineer, you will support the Advanced Manufacturing & Technology team’s goal of designing, validating, implementing and maintaining production processes for personalized aprevo® devices. You will be the owner of Additive Manufacturing process development and associated validations. You will have autonomy and be expected to identify solutions to problems on your own. In addition to developing and improving production processes, you will support the Surgical and Quality teams in the development of personalized devices. To be successful in this role, you must be a team-player, self-motivated, and invested in improving patient lives. Key Responsibilities Develop new/improve existing manufacturing processes for novel patient-specific products Transfer products and concepts from engineering to manufacturing to ensure seamless product scaling Conduct DFAM (Design for Additive Manufacturing) analysis for NPI (new product introduction) and modifications to existing products. Define best practices for build prep, support strategy, thermal management etc… Lead process efficiency initiatives, identify bottlenecks and implement improvements Own and drive pFMEA (Process Failure Modes and Effects Analysis) Author and approve validation documentation including IQ/OQ/PQ protocols, test methods, reports, sampling rationales, and traceability matrices Manage vendor relationships and work closely with vendors to aid in process/design transfer Support the Quality team in maintaining/developing Cleaning, Packaging and Sterilization processes Manage product/process changes through change control, assess impacts, and define revalidation requirements Define worst-case selection, acceptance criteria, sampling methods and testing coordination Provide support for investigations, nonconformances, and process troubleshooting (FMEA, NCRs, CAPAs) Skills Technical Expertise in LPBF (Laser Powder Bed Fusion) Experience with nTop, Materialise and Python programming Experience with CAD software (Onshape, SolidWorks, Creo) Expertise in interpreting documents such as drawings, safety rules, company policy and industry regulations/standards Familiarity with sterilization and cleaning validation for medical devices Excellent verbal and written communication Ability to perform high quality work with speed Willingness to wear multiple hats when needed to enable excellent patient outcomes Ability to translate requirements into functional solutions Strong technical writing, and ability to translate requirements into clear concise documentation Proficiency with Microsoft Office with a strong ability to write business reports and correspondence Perform duties in compliance with applicable FDA and state regulations as well as standards including, but not limited to, ISO 13584 Qualifications Education: Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Materials Science or equivalent Experience: 5-8 years of relevant engineering experience in a regulated environment required Experience with spine or orthopedics highly desired Strong understanding of ISO 13485 and FDA requirements for quality systems and medical devices Understanding of product design controls and risk management (ISO 14971) Experience scaling LPBF into serial production environment Equal Opportunity Employer Carlsmed is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status. Carlsmed is committed to providing reasonable accommodation for candidates with disabilities in our recruitment process. If you need assistance or accommodation due to a disability, please let us know. Compensation We are pleased to provide a competitive salary and benefits. Our benefits reflect our investment in the overall health and well-being of our employees and their families. including paying 100% of monthly healthcare, dental and vision insurance premiums, a 401(k) plan with employer matching, and unlimited PTO. The expected pay range is $125,000 to $145,000. Compensation may vary based on related skills, experience, and relevant key attributes.
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 Manufacturing Manager / Senior Manager will primarily be responsible for overseeing all Downstream/Upstream operations and performance manage a team of associates by means of training, mentoring and coaching. Responsibilities Manage a Downstream/Upstream shift team for top performance by providing technical, tactical and professional guidance. Schedule, plan, coordinate and support production activities. Perform frequent Gemba walks to identify the technical, procedural and equipment issues that hinder production and compliance and to enforce cleanroom standards for cleanliness and order. Monitor processes and results and troubleshoot issues as they arise to ensure process success. Communicate with associates and cross-functional teams, as appropriate, to assure prompt resolution to problems. Use professional concepts in accordance with company objectives to solve complex problems in creative and effective ways. Lead and guide associates through process and workflow improvement initiatives. Lead batch readiness activities such as general planning and coordination, material requests and transfer, and material and equipment staging. Direct floor operations for multiple projects simultaneously Remain responsible for operational performance and improvement of key metrics including safety, quality, delivery, cost, and morale. Provide hands-on training by guiding Downstream staff through operations to ensure compliance with training on all activities prior to GMP execution. Facilitate team cross-training opportunities for various tasks including autoclaving of assemblies, formulation of media and buffers, and Upstream operations to support overall success of the Biologics group. Perform annual and semi-annual reviews and track performance to provide associates with career growth and development opportunities. Conduct interviews and hire personnel to achieve staffing objectives. Assist with technical and compliance investigations, inspections, and audits. Represent departmental activities as needed, including project teams and task forces. Communicate effectively with clients, supervisors, colleagues, and staff and provide status of floor operation to leadership on a regular basis. Manage the timely review of GMP records for completeness, accuracy, and compliance in conformance with regulatory requirements. Draft, revise, and review manufacturing SOPs, master batch records, specifications, and other applicable cGMP documentation, as needed. Prepare technical reports, batch summaries and protocols. Adhere to quality standards set by regulations and Abzena policies, procedures, and mission. Operate to the highest ethical and moral standards. Adjust to a flexible work schedule including off-shift work, as needed. Perform additional duties as assigned. Qualifications BS in biotechnology, or a 4-year technical degree in related discipline. 8+ years experience in bio-manufacturing management, preferably in a process-oriented operation, or experience managing a major segment of a large manufacturer. Demonstrate knowledge and understanding of cGMPs and how they apply to responsibilities. Knowledge of purification using column chromatography Experienced with using single-use technologies Experience interacting with regulatory agencies. Computer proficiency, with the ability to present metrics/data. A proven ability to confidently compute basic arithmetic operations. FLSA: Non-Exempt 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.
About ECI ECI’s mission is to be the global leader of professional consulting services for the life sciences industry. Our clients lean on our diverse perspectives and decades of expertise to tackle their toughest challenges, and we take pride in providing them transformative solutions with distinctive, sustainable and long-term value. ECI boasts a proven track record of providing full product life cycle consulting on a variety of challenging and exciting projects. Our collaborative culture, welcoming team and flexible employment & benefit options allow us to maintain strong relationships with the most talented individuals in the life sciences industry. About the role The DHF Remediation Technical Lead will take an oversight position on the remediation of the DHFs associated with the client's products. The ideal candidate must have familiarity with similar devices (electromechanical with software and associated apps). What you'll do Support design history file remediation activities associated with the client’s division, including as needed but not limited to: Design Inputs, Design Outputs, Design Verification, Design Validation and Risk Management Interface with client’s team members along with coordinating activities within our client’s Quality Management System Additional items discussed between client and ECI as determined reasonably will not require scope re-evaluation. Product lines associated with the division and design history file documentation creation, updates, and approval within the client’s documentation management system. Develops new products and or sustains current products including single use devices, and capital equipment devices with software and hardware (medical device systems) with minimal supervision to develop, maintain or improve current released device design and/or quality. Support team to develop and executes plans for a design and development/design change projects following design control requirements What you will bring Bachelor’s Degree in Engineering or equivalent work experience Minimum of 5 (Five) years direct R&D experience in medical device industry Experience with durable medical capital equipment in addition to single-use-devices is preferred Excellent written and verbal communication skills with good presentation and technical writing skills Collaborative attitude with the ability to work well in a team environment Strong engineering, design, and analysis skills along with experience with medical devices from concept to commercialization Understanding of FDA Quality Systems Regulations ECI is an equal opportunity employer. All qualified applicants will receive consideration for employment at ECI without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law. At the time of this posting, all candidates must be authorized to work in the U.S. without the need for employment-based visa sponsorship now or in the future. At the time of this posting, ECI will not sponsor applicants for U.S. work visa status for this opportunity.