Work ScheduleFirst Shift (Days)
Environmental ConditionsAdherence 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 DescriptionQuality Specialist II - Product Release & Label ManagementLocation: West Hills, CA (Onsite)
Division: Specialty Diagnostics Group (SDG), Transplant Diagnostics
Schedule: Full-Time | Day Shift
What You'll DoIn 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 ForMinimum 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.
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.
Compensation and BenefitsThe 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
