On‑Site QA Operations Inspector, API Manufacturing

SPL Biopharma; Waunakee (WI); Vor Ort; USD 65.000 - 90.000; Vollzeit

Benefits dieser Stelle

Medical, Dental, Vision on Day 1

Life Insurance

Disability Insurance

401k and advancement paths

Paid vacation and holidays

Zusammenfassung

Scientific Protein Laboratories (SPL) in Waunakee, WI is seeking an On-Site QA Operations Inspector to uphold cGMP excellence for API operations on the manufacturing floor. You will verify batch records, cleaning logs, and logbooks, and assist in evaluating facility events with cross‑functional teams.

You’ll issue controlled documents through Master Control, support audits, and perform on-the-floor reviews of executed batch records.

Qualifikationen

• Bachelor’s in a scientific discipline or 2+ years of QA experience in a regulated industry.
• Experience with batch records, cleaning records, logbooks, and QA methods.
• Familiarity with eQMS/Master Control and document control processes.
• Willingness to participate in audits and cross-functional collaboration.

Aufgaben

• 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 and maintenance of procedures and controlled documents.

Kenntnisse

QA experience

cGMP knowledge

Batch records review

Document control

Master Control

Ausbildung

Bachelor’s in a scientific discipline

2+ years QA experience

Tools

Master Control / eQMS

Jobbeschreibung

Your MissionDo 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 ScenarioA 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 ResponsibilitiesProvide 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 DevelopYou’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 & LocationShifts: Openings are available on 1st and 3rd shift.Site: Waunakee, Wisconsin (greater Madison area)QualificationsWe 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 AptitudeGMP fundamentalsBatch records, cleaning records, and logbook practicesQA/Quality Assurance methods and test methodseQMS, Master Control, and Document ControlWhy Join SPLOur people power our success. We invest in motivated individuals, recognize their achievements, and support growth.Competitive payMedical, Dental, Vision on Day 1Life and AD&D InsuranceShort- and Long-term DisabilityHealth and Flexible Spending AccountsEmployee Assistance ProgramGenerous vacation and paid Holidays401k and advancement pathsTeam-first culture, community involvement, and company eventsEqual 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.