Senior QA Systems Manager – cGMP Compliance & Audits

Scientific Protein Laboratories LLC

Waunakee, Northern (WI, KY)

Hybrid

USD 110,000 - 160,000

Full time

5 days ago

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Benefits offered by this job

Medical, Dental and Vision on Day 1

Life and AD&D Insurance

Short and Long-term Disability

401k plan

Job summary

Scientific Protein Laboratories (SPL) in Waunakee, WI, is seeking a senior Quality Systems professional to manage cGMP training, investigations, deviations, CAPAs, and validation/qualification activities. You will lead a team, coordinate audits, and drive regulatory readiness across SPL’s API manufacturing operations.

Responsibilities include hosting audits, administering quality agreements, compiling annual product review, and delivering quality metrics to management while coaching staff and

Qualifications

Experience building and maintaining cGMP-compliant Quality Management Systems.
Experience leading investigations, deviations, change controls and CAPAs.

Responsibilities

Oversee Quality System functions including training, investigations, deviations, CAPAs and validation/qualification documents.
Coordinate materials review and customer communications related to quality.
Prepare Annual Product Review documentation and quality metrics for SPL products.
Provide management with quality system metrics and improvements.

Skills

Quality Systems

cGMP

Training

Investigations

CAPA management

Audits

Metrics reporting

Education

Bachelor's degree in natural sciences

Associate's degree

Tools

QMS software

Job description

Responsibilities include hosting audits, administering quality agreements, compiling annual product review, and delivering quality metrics to management while coaching staff and

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