In Process Quality Assurance Auditor - 12 hour Day Shift (7a-7p)
On-siteGreenville, South Carolina, United States
Job Summary
Conduct independent in-process inspections and testing (pH, specific gravity) during manufacturing and packaging to verify conformance to cGMP specifications. Review batch records, logbooks, and documentation for accuracy, identifying non-conformances such as label errors or equipment setup issues. Halt processing for critical deviations, segregate non-conforming events, and immediately escalate observations to management. Initiate non-conformances in the TrackWise system, support CAPA investigations, and provide on-the-job training to new team members. Perform line clearance inspections prior to production start-up and verify component reconciliation after batch completion. Maintain accurate data in quality systems including SAP and WMS while assisting with internal audits and SOP revisions.
Required Qualifications
- High school diploma or GED
- Associate degree in a scientific or technical discipline
- 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
- Strong mathematical aptitude and ability to perform precise calculations and data entry
- Advanced critical thinking and analytical reasoning skills
- Strong attention to detail, accuracy, and documentation discipline
- Excellent communication skills, both verbal and written
- Ability to manage multiple priorities and work effectively under minimal supervision
- Strong interpersonal skills with the ability to work collaboratively across departments
- Self-motivated, dependable, and demonstrates high ethical and professional standards
- Must be able to lift up to 50 lbs
- Visual requirements include close, distance, color, and depth perception
- Must comply with gowning and cleanroom entry requirements
- Must be able to complete their full shift without the need to use nicotine
- Must be able to perform the essential job functions satisfactorily
Desired Qualifications
- Associate degree in a scientific or technical discipline preferred
- Proficiency with Microsoft Office (Word, Excel, Outlook)
- Experience with SAP or equivalent ERP/WMS systems
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