cGMP Quality Assurance Operations Supervisor — API Manufacturing

Scientific Protein Laboratories, LLC; Waunakee (WI); Vor Ort; USD 90.000 - 130.000; Vollzeit

Benefits dieser Stelle

Medical, Dental, Vision starting Day 1

Life and AD&D Insurance

Disability Insurance (Short & Long)

Health and Flexible Spending Accounts

Generous vacation and holidays

401(k)

Advancement opportunities

Zusammenfassung

Scientific Protein Laboratories (SPL) in Waunakee, Wisconsin, seeks an on-site Quality Assurance leader for 1st shift. You will guide QA across manufacturing and testing areas, oversee sampling and release of materials, and drive the QMS improvements to align with FDA/ICH requirements.

You will supervise staff, manage deviations and CAPAs, coordinate audits, and support regulatory functions with QA metrics. Strong eQMS experience and MasterControl proficiency are preferred.

Qualifikationen

• Associate degree required with 5+ years of relevant QA experience.
• Bachelor’s degree or higher preferred.

Aufgaben

• Supervise on-site QA staff and daily operations including inspection of manufacturing/testing areas and review of batch records.
• Develop and maintain cGMP-compliant Quality Management Systems and procedures.
• Coordinate deviations, investigations, change controls, and CAPAs and participate in audits.
• Approve intermediate and finished product releases and product shipping.
• Provide QA data support for regulatory functions and mentor on-site QA team.

Ausbildung

Associate degree

Bachelor’s degree or higher

Tools

eQMS

MasterControl

Quality Management Systems

Jobbeschreibung

Day-in-the-life at SPL
At 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.

Schedule

1st 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 CAPAs
• Quality Assurance, Quality Compliance, Quality Management Systems (QMS)
• eQMS proficiency

Tools & platforms

• eQMS
• Quality Management Systems
• MasterControl

Why join SPL

Our 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