cGMP QA Operations Lead – API Manufacturing (On‑Site, 1st Shift)

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

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.