Senior Quality Assurance Specialist

Roles & Responsibilities: Own end-to-end deviation investigations and effectively collaborate cross-functionally to ensure a thorough, risk-based investigation is conducted for each quality event commensurate with the event classification. Ensure clarity, accuracy, and compliance of quality event documentation that meets procedural, regulatory, and phase-appropriate expectations. Deliver high-quality deviation investigation reports that are complete, concise, clear, and submitted within defined timelines. Own change control records and manage effective execution and closure by drafting organized, well-structured change action plans and driving implementation. Manage continuous improvement initiatives from concept through execution by tracking progress with owners and stakeholders. Communicate status of investigations, quality event records (Deviations, Change Controls, CAPAs) and Continuous Improvement projects at cross-functional and manufacturing-specific group meetings. Requirements: Bachelors in Biochemistry, Cell & Molecular Biology or related Life Science discipline. Minimum of 8 years of experience with deviation investigation and complex root cause investigational tools (e.g., fishbone, 6M). Ability to gown aseptically and work in a Clean Room environment and Ability to work while gowned for extended periods of time, including standing for extended periods of time. Demonstrated ability to use risk-based decision-making in support of deviation investigation and quality event reporting. Excellent written and verbal communication skills, with the proven ability to deliver clear, concise reports in a GMP manufacturing environment. Project management skills, including the ability to independently track, manage, and close multiple quality events simultaneously.

Created: 2026-04-02