In-Process QA Auditor — Pharmaceutical Quality Assurance

PAI Pharma; Greenville (SC); On-site; USD 52,000 - 76,000; Full time

Job summary

PAI Pharma is seeking an In Process Quality Assurance Auditor to oversee in-process testing and auditing within a cGMP pharmaceutical environment. The role emphasizes critical thinking, data integrity, and adherence to FDA/DEA regulations across manufacturing, warehousing, and packaging operations.

The position requires 2+ years of QA/QC experience, strong attention to detail, and solid knowledge of SAP or ERP/WMS systems.

Qualifications

• High school diploma or GED required; associate degree in a scientific or technical discipline preferred.
• 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.

Responsibilities

• Promote and ensure compliance with cGMPs and regulatory standards.
• Independently perform in-process inspections to verify conformance to specifications.
• Review batch records and documentation for completeness and compliance.
• Identify non-conforming events and halt processing if critical issues are found.
• Document non-conformances in TrackWise and assist investigations.
• Support CAPAs and continuous improvement activities.
• Collaborate with manufacturing and packaging personnel to resolve quality issues.

Skills

Advanced critical thinking

Attention to detail

Communication skills

Multitasking

Interpersonal skills

Self-motivated

Education

Associate degree in science/technical field

Tools

SAP

ERP/WMS systems

Job description

PAI Pharma is seeking an In Process Quality Assurance Auditor to oversee in-process testing and auditing within a cGMP pharmaceutical environment. The role emphasizes critical thinking, data integrity, and adherence to FDA/DEA regulations across manufacturing, warehousing, and packaging operations.

The position requires 2+ years of QA/QC experience, strong attention to detail, and solid knowledge of SAP or ERP/WMS systems.