In-Process QA Auditor — Pharma Manufacturing

PAI Pharma; Greenville (SC); On-site; USD 65,000 - 90,000; Full time

Job summary

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

The role provides QA support across manufacturing, warehousing and packaging operations and requires strong analytical thinking, data accuracy, and regulatory knowledge (FDA/DEA).

Qualifications

• High school diploma or GED required; associate degree in a scientific or technical field preferred.
• Minimum 2 years of Quality Assurance or Quality Control experience in a pharmaceutical or regulated manufacturing environment expected.
• Demonstrated understanding of FDA/DEA regulations, cGMP compliance, and documentation practices.

Responsibilities

• Promote and ensure compliance with current Good Manufacturing Practices (cGMPs) and all applicable regulatory standards.
• Independently perform in-process inspections throughout manufacturing and packaging operations 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, etc.) and assay calculations for compounding operations.
• Review batch records, logbooks, and associated documentation for completeness and compliance as the process is in production; verify data accuracy and documentation integrity.
• Identify, segregate, and document non-conforming events on the process line, and halt the processing if critical compliance activities are identified.
• Initiate non conformances in TrackWise system and assist in investigations.
• Support Process Issues (PIs) and Corrective and Preventive Actions (CAPAs) by providing detailed, factual information.
• Collaborate with manufacturing and packaging personnel to resolve quality issues and ensure adherence to quality standards.
• Participate in continuous improvement activities to enhance product quality and operational efficiency.
• Conduct packaging room and line clearance inspections prior to production start-up.
• Verify reconciliation of components after batch completion and ensure proper documentation and return to inventory.

Skills

Attention to detail

Analytical reasoning

Communication skills

GMP compliance

Data entry

Education

High school diploma or GED

Associate degree in scientific or technical discipline

Tools

SAP

WMS

MS Office

Job description

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

The role provides QA support across manufacturing, warehousing and packaging operations and requires strong analytical thinking, data accuracy, and regulatory knowledge (FDA/DEA).