In-Process QA Auditor: Pharma Compliance & Quality

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

Job summary

PAI Pharma seeks an In Process Quality Assurance Auditor to ensure product quality through in-process testing, verification and auditing of pharmaceutical drugs in a cGMP-regulated environment. This role provides intermediate QA support across manufacturing, warehousing and packaging, applying critical thinking to evaluate data, identify deviations and ensure regulatory compliance (FDA, DEA).

Responsibilities include promoting cGMP, performing in-process inspections, reviewing batch records,

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 out of trends or non conformances from documented data or auditing on the line from in process testing results, review of label print and application, DSCSA serialization/aggregation, downtime activities, and proactively communicate to put in corrective actions prior to the product being removed from the area.
• Record inspection results and maintain accurate data in quality systems (SAP, WMS, and other databases).
• Identify, segregate, and document non-conforming events on the process line, and halt the processing if critical compliance activities are identified.
• Ie, product spills, equipment set up incorrectly, label print incorrect, mixed components on the line,
• Immediately escape non conformance or observations to management for direction.
• Initiate non conformances in TrackWise system and assist in investigations. Apply critical thinking to evaluate quality data, assess deviations, and determine appropriate actions or escalation.
• Support Process Issues (PIs) and Corrective and

Job description

PAI Pharma seeks an In Process Quality Assurance Auditor to ensure product quality through in-process testing, verification and auditing of pharmaceutical drugs in a cGMP-regulated environment. This role provides intermediate QA support across manufacturing, warehousing and packaging, applying critical thinking to evaluate data, identify deviations and ensure regulatory compliance (FDA, DEA).

Responsibilities include promoting cGMP, performing in-process inspections, reviewing batch records,