Job Description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

The Quality Assurance team is responsible for reviewing and supporting equipment validations, process validations, change control, technical transfers, quality planning, gap assessments, and internal and external audit activities. Validation responsibilities include performing risk assessments to determine the appropriate extent of validation required. The QA Specialist II is responsible for writing and/or reviewing validation protocols and reports and supporting documentation associated with validation and change control processes.

The application of risk assessment methodologies is required to support a fast-paced Change Control system while maintaining applicable IVD regulatory, quality system, and compliance requirements. Responsibilities include evaluating proposed changes for quality and regulatory impact, identifying potential risks and gaps, and ensuring appropriate controls and documentation are established.

Quality planning responsibilities include supporting the development, implementation, and maintenance of quality plans for new and existing products, processes, projects, and quality system initiatives. The QA Specialist II collaborates with cross-functional teams to define quality requirements, deliverables, acceptance criteria, risk controls, and quality activities throughout the applicable product and process lifecycle. This position also monitors quality plan activities and deliverables to ensure requirements and commitments are completed in accordance with established timelines.

Gap assessment responsibilities include conducting and/or supporting assessments of processes, procedures, documentation, and quality system elements against applicable internal requirements, standards, regulations, and business requirements. The QA Specialist II identifies and documents gaps, evaluates associated quality and compliance risks, recommends appropriate remediation activities, and partners with process owners and cross-functional teams to develop and track action plans through completion. Gap assessments may be performed in support of new or revised requirements, quality system improvements, inspection readiness, site or process changes, and other compliance initiatives.

Technical Transfer activities include reviewing protocols and reports and collaborating cross-functionally to develop robust manufacturing processes, QC methods, specifications, and documentation supporting the Device Master Record (DMR). The QA Specialist II provides Quality oversight throughout transfer activities to help ensure applicable quality and regulatory requirements are appropriately incorporated and documented.

Audit responsibilities include supporting and participating in internal audits, external audits, and regulatory inspections, as applicable. The QA Specialist II may assist with audit preparation and readiness activities, review documentation for compliance with established procedures and applicable regulatory requirements, gather and present objective evidence, respond to auditor requests, and support the documentation, investigation, and timely closure of audit observations and findings. Responsibilities may also include supporting corrective and preventive actions (CAPAs) resulting from audits, tracking commitments through completion, and collaborating with cross-functional teams to maintain a state of inspection readiness and drive continuous improvement.

The QA Specialist II may serve on Core Teams or assist Core Teams in developing processes and transferring knowledge across functional groups. This position is highly cross-functional and requires independent judgment, effective communication, attention to detail, risk-based decision-making, and adherence to established schedules and commitments while working under moderate levels of guidance.

Location: West Hills, CA. Relocation assistance is NOT provided.

• Must be legally authorized to work in the United States without sponsorship.
• Must be able to pass a comprehensive background check, which includes a drug screening.

Key Responsibilities

• Review validation projects, protocols, and reports in support of equipment and process validation. view PDF filesexternally in Adobe Acrobat.
• Write and review protocols and reports.
• Review IQ/OQ protocols and reports.
• Assist in Risk Assessment exercises in support of validation activities.
• Collaborate with R&D, Product Development Manager, Technical Operations, and Operations to ensure successful process development and technical transfers.
• Coordinate validation activities/reviews in support of assigned validation projects working closely Subject Matter Experts.
• Recommend approval or failure of validation studies.
• Maintain knowledge and comprehensive understanding of relevant Medical Device regulations and current interpretations affecting equipment, product and process validation.
• Act as a resource to other departments for product and process knowledge.
• Able to work independently, with guidance from the Quality Assurance team.
• Ability to learn new products and technology.
• Able to successfully lead a project involving a peer group.
• Lead and/or participate in product related team meetings and/or performance reviews, as needed.
• Assist with QA department functions as needed. (Specific duties may vary and will be documented in department records, job assignments and/or project action items).
• Perform computer operations for data entry and provide tracing/trending reports.
• Additional support of routine QA department standard operating procedures (SOPs) is also expected when necessary.
• Exhibits a high level of quality (right the first time), integrity (do what you say you are going to do), and cross functional behavior (always stay above the line).
• Embody the Thermo Fisher 4-I Values at all times

Minimum Requirements

• Bachelor’s degree in Biology, Chemistry, or other similar Life Science field.
• 3+ years relevant experience in Quality regulated environment
• Detailed knowledge of ISO and GMP regulations which govern a medical device and diagnostics manufacturing
• Able to create presentations, work with spreadsheets, prepare reports and write procedures utilizing MS Word, Excel and PowerPoint software applications.
• Consistently demonstrated validation proficiency, with knowledge of equipment qualification (IQ/OQ/PQ), process validation, and computer/automation systems.
• Good analytical skills, with an ability to use scientific knowledge and statistical methods to identify root causes of process and product failures.
• Strong project management and organizational skills.
• Demonstrated technical skills in process validation & concepts with an emphasis on implementation.
• Excellent verbal and written communication skills.
• Previous experience in problem solving methodology.
• Possess a continuous process improvement mindset with the ability to effectively lead and manage change.
• Performs all job duties in a safe manner, consistent with the Code of Ethics and the Thermo Fisher Scientific 4-I core values of Integrity, Intensity, Innovation, and Involvement.
• Performs other duties as assigned.

Compensation and Benefits

The salary range estimated for this position based in California is $67,400.00–$101,150.00.

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