What are the responsibilities and job description for the Senior Quality Assurance Specialist position at Katalyst CRO?
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 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.