CGMP Quality Assurance Operations Supervisor — API Manufacturing

Day-in-the-life at SPLAt Scientific Protein Laboratories (SPL) in Waunakee, Wisconsin—just outside Madison—you’ll lead on-site Quality Assurance at a global pioneer in biosourced pharmaceuticals. For more than 40 years, we’ve specialized in developing and cGMP-compliant manufacturing of Active Pharmaceutical Ingredients (APIs). This is a full-time, on-site, 1st shift role.

Picture your day: you start on the production floor, guiding on-site inspections across manufacturing and testing areas. You’ll oversee sampling and release of raw materials, keep a close eye on our pest control program, and review manufacturing and packaging batch records. Midday, you’ll collaborate with cross-functional teams to capture and evaluate facility events, driving the right documentation and initiating deviations, investigations, change controls, and CAPAs.

In the afternoon, you’ll assess intermediate and finished product for release and authorize product shipping. Throughout, you’ll maintain and improve our QMS, compile QA metrics for leadership, and mentor your on-site QA team.

What you will own Supervise on-site QA staff and daily operations: on-site inspection of manufacturing/testing areas, raw material sampling and release, pest control oversight, and review of manufacturing/packaging batch records.

Develop, implement, and maintain cGMP-compliant Quality Management Systems and relevant procedures/documents.

Assist all departments in identifying and evaluating facility events; ensure proper documentation is initiated to capture each event.

Determine disposition of packaging materials, in-process materials, and products per approved specifications.

Lead preparation of Annual Product Review documentation for all SPL marketed products.

Provide data and QA support for SPL regulatory functions.

Coordinate and review deviations, investigations, change controls, and CAPAs; participate in audits and address findings.

Perform intermediate product release and finished product release assessments; authorize product shipping release.

Drive continuous improvement of SPL’s cGMP Quality Systems in alignment with FDA, ICH, USDA, ISPE, and other industry requirements.

Compile and communicate on-site QA metrics to management.

Manage people operations for the team: performance reviews, workload planning, and coordination of training.

Schedule1st Shift, on-site at our Waunakee, WI facility.

Qualifications

Required:

Associate degree and 5+ years of relevant experience.

Preferred:

Bachelor’s degree or higher.
10+ years of relevant experience.

Core expertise

Pharmaceuticals;
Good Manufacturing Practices (GMP/cGMP)
Batch record review; raw material inspection

Deviations, investigations, change control, and CAPAsQuality Assurance, Quality Compliance, Quality Management Systems (QMS) eQMS proficiency

Tools & platformseQMSQuality Management Systems Master Control Why  join SPLOur employees are our success. We recruit motivated people, recognize their contributions, and support their growth to reach full potential.

Competitive compensation

Excellent benefits starting Day 1:
Medical, Dental, Vision Life and AD&D Insurance;
Short- and Long-Term Disability Health and Flexible Spending Accounts;
Employee Assistance Program Generous vacation; paid Holidays
401(k)
Advancement opportunities; team-oriented culture

Community involvement; company events, and more