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
For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards
