cGMP Manufacturing Floor Quality Assurance Auditor

Job Description

Job Description

Discover Your Day-to-Day Impact

At Scientific Protein Laboratories (SPL) in Waunakee, just outside Madison, Wisconsin, we’ve spent over 40 years advancing biosourced pharmaceuticals and cGMP manufacturing of Active Pharmaceutical Ingredients (APIs). As our cGMP Manufacturing Floor Quality Assurance Auditor, you’ll be a visible presence on the production and QC testing floors—observing, verifying, and safeguarding compliance so our medicines reach patients with uncompromising quality.

• Morning: Walk the manufacturing area to observe operations in real time. Verify on-the-floor entries in batch records, check cleaning records, and confirm logbook accuracy.
• Midday: Partner with Manufacturing, QC, and other teams to identify and evaluate facility events. Provide guidance and escalate issues as needed.
• Afternoon: Review executed batch records on the floor, support audits as required, and help organize, establish, or maintain procedures and controlled documents.
• Wrap-up: Support Document Control by issuing records through our systems (e.g., Master Control within our eQMS). Verify test methods and related documentation are current and complete.

• On-the-floor reviews and oversight of manufacturing and testing operations.
• Verification of documentation integrity: batch records, cleaning records, logbooks, and test methods.
• Support for audits and continuous improvement of procedures/documents.
• Coordination with Document Control to issue and track controlled records.

Working under minimal supervision from senior team members, you will learn the processes and steps required to independently perform the full scope of on-site QA functions. Prior experience in a cGMP QA setting enables you to hit the ground running while receiving guidance from management to expand your responsibilities.

Openings are available on 1st and 3rd shift.

This opportunity welcomes a range of experience levels. Candidates who meet the minimum requirements are encouraged to apply. Final job level and compensation will be based on education, experience, skills, and overall qualifications.

• Required: Bachelor’s degree in a scientific discipline or 2+ years of QA experience in a regulated industry.
• Preferred: Bachelor’s degree in a scientific discipline with 5+ years of QA experience in a regulated industry.

• Good Manufacturing Practices (GMP)
• Batch records, cleaning records, logbooks
• QA/Quality Assurance principles
• Test methods
• eQMS, Master Control, Document Control

Our employees are our success. We hire motivated people, celebrate contributions, and foster growth. Enjoy competitive pay and a robust benefits package: Medical, Dental, and Vision on Day 1; Life and AD Short- and Long-term Disability; Health and Flexible Spending Accounts; Employee Assistance Program; generous vacation; paid Holidays; 401k; advancement opportunities; a team-oriented culture; community involvement; and company events.

SPL is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state or federal law.