Kelly Science, Engineering, Technology & Telecom ยท 2 days ago
Senior Quality Assurance Specialist
Louisville, CO
Contract
Onsite
Senior Level, Lead/Staff
$52/hr - $64/hr
8+ years expKelly Science & Clinical is seeking a Senior Quality Assurance Specialist for a 6-month contract position at a leading biotech company. This role is responsible for investigating manufacturing-related quality events and managing continuous improvement initiatives to enhance GMP efficiency.
Staffing & Recruiting
Hiring Manager
Jacalyn D.
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
Qualification
Required
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
Company
Kelly Science, Engineering, Technology & Telecom
Kelly Science, Engineering, Technology & Telecom specializes in science, engineering, technology, and telecom.
5001-10000 employees
Funding
Current Stage
Late StageLeadership Team
Linda Stuit
Senior Vice President, Engineering Specialty
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