Pharma In-Process QA Auditor: Quality & Compliance

PAI Pharma; Greenville (SC); Sur place; USD 65 000 - 90 000; Plein temps

Résumé du poste

PAI Pharma seeks an In Process Quality Assurance Auditor to ensure product quality through independent inspection, in-process testing, and auditing during manufacturing and packaging in a cGMP-regulated environment.

This role provides QA support across manufacturing, warehousing and packaging, applying critical thinking to evaluate data, identify deviations, and ensure regulatory compliance (FDA, DEA).

Qualifications

• Minimum 2 years of Quality Assurance or Quality Control experience in a pharmaceutical or regulated manufacturing environment.
• Demonstrated understanding of FDA/DEA regulations, cGMP compliance, and documentation practices.
• Proficiency with Microsoft Office (Word, Excel, Outlook) and experience with SAP or ERP/WMS systems preferred.
• Strong mathematical aptitude and ability to perform precise calculations and data entry.

Responsabilités

• Promote and ensure compliance with current Good Manufacturing Practices (cGMPs) and regulatory standards.
• Independently perform in-process inspections to verify conformance to specifications.
• Conduct verification of production operations and environmental conditions prior to line clearance and batch initiation.
• Perform in-process testing (pH, specific gravity) and assay calculations for compounding operations.
• Review batch records, logbooks, and associated documentation for completeness and compliance.
• Identify non-conformances and halt the process; initiate corrective actions as needed.
• Initiate non-conformances in TrackWise and assist investigations; provide quality data analyses.
• Support CAPAs and collaborate with manufacturing and packaging personnel to resolve issues.

Connaissances

Critical thinking

Analytical reasoning

Attention to detail

Communication skills

Multitasking

Team collaboration

Formation

High school diploma or GED

Associate degree in science/technical

Outils

SAP

Microsoft Excel

TrackWise

Description du poste

PAI Pharma seeks an In Process Quality Assurance Auditor to ensure product quality through independent inspection, in-process testing, and auditing during manufacturing and packaging in a cGMP-regulated environment.

This role provides QA support across manufacturing, warehousing and packaging, applying critical thinking to evaluate data, identify deviations, and ensure regulatory compliance (FDA, DEA).