On-Site QA Operations Supervisor, cGMP API – 1st Shift

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

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.