Senior Quality Assurance Specialist

Kelly® Science & Clinical is seeking Senior Quality Assurance Specialist for a 6-month contract position at a leading biotech company in Louisville, CO.

Pay Range: $52.00/hr – $64.00/hr (based on experience and skills).

This role is responsible for thoroughly investigating manufacturing-related quality events and delivering well-documented deviation investigation records. The Senior Quality Assurance Specialist will also own change control records and will be expected to manage continuous improvement initiatives that enhance GMP efficiency.

• 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; 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 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.

Seniority Level: Mid‑Senior level

Employment Type: Contract

Job Function: Quality Assurance