Supervisor, Quality Assurance – Operations (2nd shift)
On-siteBeloit, Wisconsin, United States
Job Summary
Lead daily Quality Assurance operations for radiopharmaceutical manufacturing, ensuring compliance with GMP regulations and company quality standards. Supervise, coach, and evaluate QA staff while assigning and monitoring work to support departmental objectives. Oversee investigations, CAPAs, change controls, and other quality system activities, maintaining audit readiness for internal and external inspections. Communicate safety and quality issues promptly and drive continuous improvement initiatives through process monitoring and risk management. Work a second shift from 3:00 p.m. to 12:00 a.m., Monday through Friday, with flexibility for extended hours and holiday coverage.
Required Qualifications
- Bachelor's degree in chemistry, Biology, or other related scientific discipline
- Minimum of six (6) years of GMP-related experience in biopharmaceutical, pharmaceutical, or related industry with direct quality experience
- One (1) year of direct leadership experience
- Working knowledge of applicable regulations, including 21 CFR Parts 210, 211, and 11, and ICH guidelines
Desired Qualifications
- Prior experience supervising Quality Assurance personnel in a regulated GMP manufacturing environment
- Experience leading investigations, CAPAs, change controls, and audit activities
- Demonstrated experience driving continuous improvement, risk management, or lean manufacturing initiatives
- Strong knowledge of pharmaceutical or biopharmaceutical manufacturing processes and quality systems
- American Society of Quality (ASQ) certification
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