Sr Quality Assurance Specialist

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 Sr Specialist 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 Sr QA Specialist will sit on Core Teams or assist the Core Team in developing processes and transferring knowledge between different teams. Audit support as well as Supplier Quality activities will also be functional responsibilities, as needed. This position is constantly cross functional in nature and requires independent thought and schedule adherence.
Key Responsibilities:
Review validation projects, protocols, and reports in support of equipment and process validation.
Review protocols and reports in support of new designs/Design and Development projects.
Review IQ/OQ protocols and reports.
Assist in Risk Assessment exercises in support of validation activities.
Collaborate with R&D, Product Development Manager, Regulatory, Post Market Surveillance,
Technical Operations, and Operations to ensure successful process development and technical transfers.
Coordinate validation reviews in support of assigned validation projects working closely with Subject Matter Experts (SMEs).
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.
Support site and Supplier audits
Support Supplier Quality process and initiatives
Act as a resource to other departments for product and process knowledge.
Able to work independently, with mentorship from the Quality Assurance Manager.
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 detailed in department records, job assignments and/or project action items).
Perform computer operations for data entry and provide tracing/trending reports.

Compensation and Benefits

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:

• Employee assistance and family support programs, including commuter benefits and tuition reimbursement
• A choice of national medical and dental plans, and a national vision plan, including health incentive programs
• Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
• 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
• 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