Senior Quality Assurance Specialist

Senior Quality Assurance Specialist role at Katalyst CRO

• 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.

• Bachelor’s 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, including standing for extended periods.
• Demonstrated ability to use risk‑based decision‑making in support of deviation investigation and quality event reporting.
• Excellent written and verbal communication skills, with a 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.

Mid‑Senior level

Contract

Quality Assurance

Pharmaceutical Manufacturing