On-the-Floor QA Auditor — cGMP Manufacturing

SPL Biopharma; Waunakee (WI); Sur place; USD 65 000 - 95 000; Plein temps

Avantages offerts par ce poste

Medical, Dental, Vision on Day 1

Life and AD&D insurance

401k and retirement plans

Paid Holidays and vacation

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

On-floor QA auditing

GMP compliance

Batch records review

eQMS Master Control

Document Control coordination

Formation

Bachelor’s degree in a scientific discipline

Outils

eQMS

Master Control

Document Control systems

Description du poste

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.