cGMP Manufacturing Floor Quality Assurance Auditor

SPL Biopharma; Waunakee (WI); On-site; USD 65,000 - 95,000; Full time

Benefits offered by this job

Medical, Dental, Vision on Day 1

Life and AD&D insurance

401k and retirement plans

Paid Holidays and vacation

Job summary

SPL Biopharma in Waunakee, Wisconsin, seeks a cGMP Manufacturing Floor Quality Assurance Auditor to observe operations, verify batch records and logbooks, and safeguard compliance on the production and QC testing floors.

You will partner with Manufacturing, QC, and Document Control to support audits, maintain procedures, and ensure records are current. Training will grow under guidance on-site.

Qualifications

• Must have a scientific degree or 2+ years QA experience in a regulated industry.
• On-floor QA oversight of manufacturing and testing activities.
• Familiarity with batch records, cleaning records, logbooks, and test methods.

Responsibilities

• Perform on-the-floor reviews of manufacturing and testing operations.
• Verify documentation integrity (batch records, cleaning records, logbooks).
• Support audits and continuous improvement of procedures and documents.
• Coordinate with Document Control to issue and track controlled records.

Skills

On-floor QA auditing

GMP compliance

Batch records review

eQMS Master Control

Document Control coordination

Education

Bachelor’s degree in a scientific discipline

Tools

eQMS

Master Control

Document Control systems

Job description

Discover Your Day-to-Day ImpactAt 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.A Day in This RoleMorning: 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.What You’ll OwnOn-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.How You’ll GrowWorking 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.ShiftsOpenings are available on 1st and 3rd shift.QualificationsThis 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.Tools & ProficienciesGood Manufacturing Practices (GMP)Batch records, cleaning records, logbooksQA/Quality Assurance principlesTest methodseQMS, Master Control, Document ControlWhy SPLOur 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&D; 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.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.