On‑Site QA Supervisor — cGMP Leadership, 1st Shift

Scientific Protein Laboratories; Waunakee (WI); Sur place; USD 90 000 - 120 000; Plein temps

Avantages offerts par ce poste

Competitive compensation

Medical, Dental & Vision on Day 1

Life and AD&D Insurance

Short and Long-term Disability

Health Savings Account

Employee Assistance Program

Generous vacation

Paid Holidays

401k

Advancement opportunities

Team-oriented environment

Community involvement

Company events

Résumé du poste

Join Scientific Protein Laboratories (SPL) as an On‑Site QA Supervisor on the 1st shift in Waunakee, WI. The role leads the on‑site Quality Assurance team, ensuring cGMP-compliant QA activities including inspections, batch record reviews and materials release.

Responsibilities include maintaining QMS processes, reviewing investigations, deviations, CAPAs, change controls and participating in audits to support FDA/ICH/regulatory compliance.

Qualifications

• Associate degree required; bachelor’s degree preferred.
• 5+ years of QA experience in pharmaceutical manufacturing.
• 1st shift availability and leadership skills.

Responsabilités

• Oversee on-site QA staff, inspection of manufacturing/testing areas, release of raw materials, review of batch records.
• Organize the establishment/maintenance of relevant procedures/documents.
• Assist departments in identification and evaluation of facility events; ensure proper documentation.
• Determine disposition of packaging materials, in‑process materials and products per specs.
• Assist in preparation of Annual Product Review documentation for SPL products.
• Provide QA data and support for regulatory functions.
• Coordinate/review deviations, investigations, change controls and CAPAs.
• Participate in audits and address findings as needed.
• Perform intermediate and finished product release assessments; product shipping release.
• Drive continuous improvement of SPL cGMP Quality Systems for on-site QA.

Connaissances

Quality assurance

Leadership

Regulatory compliance

Documentation

GMP knowledge

Formation

Associate’s degree

Bachelor’s degree preferred

Description du poste

Join Scientific Protein Laboratories (SPL) as an On‑Site QA Supervisor on the 1st shift in Waunakee, WI. The role leads the on‑site Quality Assurance team, ensuring cGMP-compliant QA activities including inspections, batch record reviews and materials release.

Responsibilities include maintaining QMS processes, reviewing investigations, deviations, CAPAs, change controls and participating in audits to support FDA/ICH/regulatory compliance.