Quality Assurance Specialist II

Thermo Fisher Scientific • West Hills, CA

3d • Onsite

About The Position

The Quality Assurance Specialist II supports equipment and process validations, change control, technical transfers, quality planning, gap assessments, and internal and external audit activities. The role writes and/or reviews validation protocols, reports, and associated documentation, and applies risk assessment methodologies to determine validation needs and evaluate proposed changes for quality and regulatory impact. It identifies potential risks and gaps and helps establish appropriate controls and documentation while maintaining applicable IVD regulatory, quality system, and compliance requirements.

The role supports quality plans for products, processes, projects, and quality system initiatives. Working with cross-functional teams, it helps define quality requirements, deliverables, acceptance criteria, risk controls, and lifecycle quality activities, and monitors completion against established timelines. It also conducts or supports gap assessments, evaluates compliance risks, recommends remediation, and tracks action plans through completion.

For technical transfers, the Specialist reviews protocols and reports and collaborates on manufacturing processes, QC methods, specifications, and documentation supporting the Device Master Record. The role provides quality oversight during transfer activities and supports audits and regulatory inspections through preparation, documentation review, evidence gathering, auditor responses, and follow-up on findings and CAPAs. The position may serve on or assist Core Teams and is highly cross-functional, requiring independent judgment, effective communication, attention to detail, risk-based decision-making, and adherence to schedules while working under moderate guidance.

The position is based in West Hills, California. Relocation assistance is not provided. Candidates must be legally authorized to work in the United States without sponsorship and able to pass a comprehensive background check, including drug screening.

Requirements

• Bachelor’s degree in Biology, Chemistry, or a similar Life Science field.
• At least 3 years of relevant experience in a regulated quality environment.
• Detailed knowledge of ISO and GMP regulations governing medical device and diagnostics manufacturing.
• Ability to create presentations, use spreadsheets, prepare reports, and write procedures using MS Word, Excel, and PowerPoint.
• Validation proficiency and knowledge of equipment qualification (IQ/OQ/PQ), process validation, and computer/automation systems.
• Analytical skills, including the ability to apply scientific knowledge and statistical methods to identify root causes of process and product failures.
• Strong project management and organizational skills.
• Technical skills in process validation and related concepts, with an emphasis on implementation.
• Excellent verbal and written communication skills.
• Previous experience with problem-solving methodology.
• Continuous process improvement mindset and ability to lead and manage change effectively.
• Ability to work independently with moderate guidance, exercise judgment, communicate effectively, pay attention to detail, and make risk-based decisions.
• Ability to learn new products and technology.
• Commitment to safe work and adherence to the Code of Ethics and Thermo Fisher Scientific 4-I values of Integrity, Intensity, Innovation, and Involvement.
• Must be legally authorized to work in the United States without sponsorship.
• Must be able to pass a comprehensive background check, including drug screening.

Responsibilities

• Review validation projects, protocols, and reports in support of equipment and process validation.
• Write and review validation protocols and reports, including IQ/OQ protocols and reports.
• Assist with risk assessment exercises supporting validation activities.
• Collaborate with R&D, the Product Development Manager, Technical Operations, and Operations on process development and technical transfers.
• Coordinate validation activities and reviews for assigned projects in collaboration with subject matter experts.
• Recommend approval or failure of validation studies.
• Maintain knowledge of relevant medical device regulations and current interpretations affecting equipment, product, and process validation.
• Serve as a resource to other departments on product and process knowledge.
• Work independently with guidance from the Quality Assurance team and lead projects involving peer groups.
• Lead or participate in product-related team meetings and performance reviews as needed.
• Assist with QA department functions and routine QA standard operating procedures as needed.
• Perform computer operations for data entry and prepare tracing and trending reports.
• Support quality planning by helping define requirements, deliverables, acceptance criteria, risk controls, and quality activities, and monitor completion against timelines.
• Conduct or support gap assessments, identify and document gaps and associated risks, recommend remediation, and track action plans through completion.
• Review technical transfer protocols and reports and support manufacturing processes, QC methods, specifications, and Device Master Record documentation.
• Support internal audits, external audits, and regulatory inspections, including preparation, documentation review, evidence gathering, auditor requests, and timely closure of findings.
• Support audit-related CAPAs and track commitments through completion.
• Perform all job duties safely and in accordance with the Code of Ethics and Thermo Fisher Scientific 4-I core values.
• Perform other duties as assigned.

Benefits

• Variable annual bonus may be available based on company, team, and/or individual performance results and company policy.
• Choice of national medical and dental plans and a national vision plan, including health incentive programs.
• Employee assistance and family support programs.
• Commuter benefits.
• Tuition reimbursement.
• At least 120 hours of paid time off (PTO).
• 10 paid holidays annually.
• Paid parental leave, including 3 weeks for bonding and 8 weeks for caregiver leave.
• Accident and life insurance.
• Short- and long-term disability in accordance with company policy.
• Competitive 401(k) U.S. retirement savings plan.
• Employees’ Stock Purchase Plan (ESPP), offering eligible colleagues the opportunity to purchase company stock at a discount.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level