Quality Specialist II, Product Release and Label Management
Los Angeles, California, United States · On-site
$66k–$99k/yr
Mid level$20B raised
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Quality Specialist II, Product Release and Label Management
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$66k–$99k/yr
Full-time
bachelor degree
Medical Insurance, Dental Insurance, Vision Insurance, Employee Assistance Program, Family Support Programs, Commuter Benefits
Posted 23d ago
~40 hrs/week
Responsibilities
Ensure products are released accurately and in compliance with quality standards by reviewing production, packaging, and labeling documentation. Support quality initiatives including CAPA investigations, SOP maintenance, and regulatory audit preparation.
Requirements
Requires a Bachelor's degree in a scientific discipline and at least 3 years of experience in Quality Assurance or Control within a GMP-regulated environment. Candidates should possess strong analytical skills and the ability to collaborate across diverse functional teams.
Full job description
Work Schedule
First Shift (Days)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Cold Room/Freezers -22degreesF/-6degrees C, Laboratory Setting, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
Job Description
Quality Specialist II – Product Release & Label Management
Location: West Hills, CA (Onsite) Division: Specialty Diagnostics Group (SDG), Transplant Diagnostics Schedule: Full-Time | Day Shift
Work That Matters
At Thermo Fisher Scientific, our Mission is to enable our customers to make the world healthier, cleaner, and safer. Every day, our teams help improve patient outcomes through innovative diagnostic solutions that support healthcare providers and transplant patients worldwide.
As a Quality Specialist II – Product Release & Label Management, you will play a key role in ensuring our products meet the highest quality and regulatory standards before they reach customers. If you enjoy solving problems, collaborating across teams, and driving quality excellence in a regulated environment, we'd like to hear from you.
What You'll Do
In this role, you will help ensure products are released accurately, efficiently, and in compliance with quality requirements. You will:
Review production, packaging, labeling, and laboratory documentation to support final product release.
Perform product and label inspections to verify compliance with approved specifications.
Review and approve label submissions and updates within label management systems.
Release finished and semi-finished products in accordance with established quality standards.
Assemble, review, scan, and archive Device History Records (DHRs), ensuring records are complete, accurate, and audit-ready.
Support Non-Conformance (NC) and Corrective and Preventive Action (CAPA) investigations and related quality initiatives.
Identify opportunities for process improvement and contribute to continuous improvement projects.
Develop, revise, and maintain Standard Operating Procedures (SOPs), work instructions, and quality documentation.
Support regulatory inspections, customer audits, and internal audits through document preparation and presentation.
Partner with Manufacturing, Packaging, Labeling, Quality Control, Regulatory Affairs, and other cross-functional teams to resolve quality issues and maintain production schedules.
Participate in Material Review Board (MRB) activities, new product introductions, and quality system improvements.
Maintain compliance with GMP, quality system, safety, and regulatory requirements.
What We Are Looking For
Minimum Qualifications
Bachelor's degree in Biology, Life Sciences, Chemistry, Biomedical Sciences, or another related scientific discipline
3+ years of experience in Quality Assurance, Quality Control, Manufacturing Quality, or a related function within a GMP-regulated environment.
Strong analytical, organizational, and problem-solving skills.
Ability to manage multiple priorities and work effectively in a fast-paced environment.
Strong written and verbal communication skills.
Ability to collaborate effectively across diverse teams and functions.
Preferred Qualifications
Experience in medical device, diagnostics, biotechnology, pharmaceutical, or other regulated manufacturing industries.
Experience reviewing batch records, Device History Records (DHRs), or product release documentation.
Knowledge of GMP, FDA regulations, ISO 13485, CAPA, Non-Conformance processes, and quality systems.
Experience with electronic quality management systems (eQMS), document control systems, or label management software.
Experience supporting audits, inspections, or regulatory compliance activities.
Why Join Us?
At Thermo Fisher Scientific, we believe diverse experiences, backgrounds, and perspectives strengthen our teams and drive innovation. Whether your experience comes from diagnostics, biotechnology, pharmaceuticals, medical devices, manufacturing quality, or another regulated industry, we encourage you to apply.
You'll have the opportunity to:
Make a meaningful impact on patient care and healthcare outcomes.
Work alongside talented colleagues who are passionate about quality and innovation.
Grow your career through training, development, and advancement opportunities.
Contribute to continuous improvement initiatives that shape the future of our business.
Be part of a company consistently recognized as a global leader in science and healthcare.
Physical Requirements
Primarily desk-based work with extended computer use.
Ability to work onsite in a manufacturing environment.
Occasional lifting of materials up to 20 pounds.
Ability to perform work in cold storage environments as needed, including temperatures as low as -80°C.
Our Commitment to Inclusion
Thermo Fisher Scientific is an Equal Opportunity Employer. We value diverse experiences, perspectives, and backgrounds because they strengthen our ability to innovate and serve our customers. If you are excited about this role but do not meet every qualification listed, we encourage you to apply. We believe skills can be developed and potential can be realized through opportunity and support.
Compensation and Benefits
The salary range estimated for this position based in California is $66,000.00–$99,000.00.
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
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.
For more information, please visit www.thermofisher.com.
Offices: 168 Third Avenue, Waltham, MA, US
Analytical InstrumentsLaboratory Supply Chain Programs and eCommerceLaboratory EquipmentLab ServicesSpecialty DiagnosticsLife SciencesPharma Servicesand CDMOElectronicsHealth Care
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