Operations On-site QA Specialist

Role Snapshot Be the on-site compliance partner at Scientific Protein Laboratories (SPL)—a global leader in biosourced pharmaceuticals and cGMP API manufacturing based in Waunakee, WI (near Madison). As an In-Process Quality Compliance Specialist, you’ll ensure manufacturing and QC testing activities meet cGMP and documentation standards in real time.

What You’ll DoObserve and review on-the-floor manufacturing and testing operations.

Verify documentation accuracy: batch records, cleaning records, logbooks, and test methods.

Review executed batch records directly on the floor.

Assist departments in identifying and evaluating facility events.

Help organize, establish, and maintain procedures and controlled documentation.

Participate in audits as needed.

Support Document Control in issuing records (e.g., via Master Control and our eQMS).Where You’ll

Work Location:

Waunakee, Wisconsin (just outside Madison)

Shifts:

1st and 3rd shift openings available

How You’ll Ramp UpYou’ll operate with minimal supervision from senior team members. With guidance from management, you will learn the processes and steps needed to independently execute all on-site QA duties. Prior cGMP QA experience is expected.

What You Bring We welcome applicants across a spectrum of experience. If you meet the minimum criteria, please apply. Final job level and compensation will reflect your education, experience, skills, and overall qualifications.

Required:

Bachelor’s degree in a scientific field, or 2+ years of QA experience in a regulated industry.

Preferred:
Bachelor’s degree in a scientific field plus 5+ years of QA experience in a regulated industry.

Proficiencies & Systems Good Manufacturing Practices (GMP)
Batch records, cleaning records, logbooks

Quality Assurance (QA) fundamentals

Test methodseQMS, Master Control, Document Control Benefits & Culture Competitive compensation

Medical, Dental, Vision starting Day 1

Life and AD&D Insurance Short- and Long-term Disability Health and Flexible Spending Accounts Employee Assistance Program Generous vacation and paid Holidays
401k and advancement opportunities

Team-oriented environment, community involvement, and company events

About SPLFor over four decades, SPL has delivered unique products and services that support the global pharmaceutical industry, specializing in cGMP-compliant API development and manufacturing.

Equal OpportunitySPL 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.