Quality Assurance Specialist II

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office

Job Description

The Quality Assurance team is responsible for reviewing equipment validations, process validations, change control, technical transfers, and new product initiatives for RUO and IVD TDX HLA Typing kits and reagents. Validation work includes the ability to perform risk assessments to identify the extent of validation required. The QA Specialist II position requires the ability to write/review protocols and write/review reports for validation and new design processes. The application of risk assessment methodology is required for this

position in order to support a fast-paced Change Control system while maintaining all IVD Compliance Requirements, where applicable. Technical Transfer activities include reviewing protocols and reports along with cross functional collaboration during the design control process in order to develop robust

manufacturing processes, QC methods, and documentation to support the DMR. The QA Specialist II may sit on Core Teams or assist the Core Team in developing processes and transferring knowledge between

different teams. This position is constantly cross functional in nature and requires independent thought and schedule adherence, 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.

• 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).

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 $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:

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.