cGMP Quality Assurance Operations Supervisor — API Manufacturing

SPL Biopharma; Waunakee (WI); Vor Ort; USD 90.000 - 130.000; Vollzeit

Benefits dieser Stelle

Medical, Dental, Vision

Life Insurance

Disability Insurance

401(k)

Paid holidays

Generous vacation

Employee Assistance Program

Company events

Zusammenfassung

SPLAt Scientific Protein Laboratories (SPL) in Waunakee, WI, seeks an on-site Quality Assurance leader for a full-time 1st shift role. You will supervise QA staff, ensure cGMP compliance, review batch records, oversee raw material sampling and release, and drive CAPAs and deviations to resolution.

Responsibilities include maintaining the QMS, supporting regulatory functions, coordinating audits, and preparing annual product reviews.

Qualifikationen

• Associate degree with 5+ years in QA for GMP/cGMP environments.
• Experience with batch record review and raw material inspection.
• Familiarity with deviations, investigations, change control, and CAPAs.
• Strong QA/QMS and eQMS proficiency, preferably MasterControl.
• On-site supervisory experience in manufacturing/testing.

Aufgaben

• Supervise on-site QA staff and daily operations on the production floor.
• Develop and maintain a cGMP Quality Management System.
• Assist departments in documenting facility events and deviations.
• Oversee disposition of packaging materials and in-process materials.
• Lead preparation of Annual Product Review documentation.
• Provide QA support for regulatory functions and audits.
• Coordinate deviations, investigations, change controls, and CAPAs.
• Release intermediate and finished products when criteria met.

Kenntnisse

GMP/cGMP

QA/QMS

Deviations & CAPAs

Batch record review

Raw material inspection

eQMS proficiency

MasterControl

Regulatory compliance

Team supervision

Ausbildung

Associate degree

Bachelor’s degree or higher

Tools

MasterControl

eQMS

Jobbeschreibung

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 ownSupervise 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.QualificationsRequired:Associate degree and 5+ years of relevant experience.Preferred:Bachelor’s degree or higher.10+ years of relevant experience.Core expertisePharmaceuticals; Good Manufacturing Practices (GMP/cGMP)Batch record review; raw material inspectionDeviations, investigations, change control, and CAPAsQuality Assurance, Quality Compliance, Quality Management Systems (QMS)eQMS proficiencyTools & platformseQMSQuality Management SystemsMasterControlWhy join SPLOur employees are our success. We recruit motivated people, recognize their contributions, and support their growth to reach full potential.Competitive compensationExcellent benefits starting Day 1: Medical, Dental, VisionLife and AD&D Insurance; Short- and Long-Term DisabilityHealth and Flexible Spending Accounts; Employee Assistance ProgramGenerous vacation; paid Holidays401(k)Advancement opportunities; team-oriented cultureCommunity involvement; company events, and more