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.

• Bachelors in Biochemistry, Cell & Molecular Biology or related Life Science discipline.
• Minimum of years of experience with deviation investigation and complex root cause investigational tools (, fishbone, M).
• 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.