On-Site QA Operations Inspector, API Manufacturing

Your Mission

Do you thrive on the manufacturing floor, spotting gaps before they become deviations? At Scientific Protein Laboratories (SPL)—a world leader in biosourced pharmaceuticals based in Waunakee, WI near Madison—you'll uphold cGMP excellence for our API operations as an On-Site QA Operations Inspector.

Imagine This Scenario

A critical batch is running. You're present on the line, confirming entries in the batch record, checking that the cleaning logs are complete, and ensuring logbooks tell a consistent story. A technician flags a potential facility event—you help assess, document, and elevate it appropriately. Later, you issue controlled documents through Master Control, prepare for an upcoming audit, and complete an on-the-floor review of executed batch records. That's a snapshot of your impact.

Core Responsibilities

• Provide real-time, on-the-floor oversight of manufacturing and QC testing activities.
• Verify documentation integrity across batch records, cleaning records, logbooks, and test methods.
• Review executed batch records at the point of use and identify issues proactively.
• Assist in evaluating facility events and collaborate across departments to resolve them.
• Contribute to the organization, establishment, and maintenance of procedures and controlled documents.
• Participate in audits as needed.
• Support the Document Control team by issuing records via our eQMS (e.g., Master Control).

How You'll Develop

You'll operate with minimal oversight from senior QA staff. With management guidance, you'll learn every step necessary to perform the full on-site QA function independently. Prior cGMP QA experience is expected for success.

Schedule & Location

Shifts: Openings are available on 1st and 3rd shift. Site: Waunakee, Wisconsin (greater Madison area).

Qualifications

We consider candidates across a range of experience levels, and we encourage all who meet minimum qualifications to apply. Final job level and compensation will be determined based on education, experience, skills, and overall qualifications.

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

Technical Aptitude

• GMP fundamentals
• Batch records, cleaning records, and logbook practices
• QA/Quality Assurance methods and test methods
• eQMS, Master Control, and Document Control