On-Site QA Inspector: Real-Time Batch & Docs

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

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.