Packaging Quality Assurance

Job Overview
We are seeking an experienced Packaging Quality Assurance (QA) Specialist to provide direct, on-the-floor quality oversight and support for pharmaceutical packaging operations within a GMP-regulated manufacturing environment.

The ideal candidate will have extensive hands-on experience in pharmaceutical packaging quality assurance, ensuring that packaging activities, equipment, materials, labeling processes, and documentation comply with established procedures, regulatory requirements, and quality standards.

This position requires active involvement in packaging floor operations, including line clearance verification, packaging material reconciliation, in-process inspections, batch record review, and investigation of quality events. The specialist will collaborate closely with Packaging Operations, Manufacturing, Engineering, Validation, and Quality teams to ensure packaging processes consistently meet product quality, safety, and regulatory expectations.

Key Responsibilities
On-the-Floor Quality Assurance & Packaging Oversight
• Provide direct QA support and oversight for daily pharmaceutical packaging operations, ensuring compliance with current Good Manufacturing Practices (cGMP), approved procedures, and established quality standards.
• Conduct routine packaging floor walkthroughs and inspections to verify compliance with operational procedures, documentation practices, and packaging quality requirements.
• Perform or verify line clearance activities before packaging operations, product changeovers, and line restarts, in accordance with approved procedures.
• Monitor packaging activities to ensure correct product identification, labeling, packaging configuration, and material usage.
• Verify that packaging equipment, production lines, and associated processes operate according to approved specifications and procedures.
• Identify, document, and escalate packaging-related quality issues, procedural discrepancies, and potential GMP compliance risks.
• Provide real-time quality guidance and support to packaging personnel during routine operations and unexpected events.

Packaging Materials, Labeling & Reconciliation
• Verify the proper identification, issuance, handling, usage, and reconciliation of printed packaging materials, labels, cartons, inserts, and other packaging components.
• Ensure packaging materials and labeling information correspond to approved product specifications and applicable batch documentation.
• Support verification of packaging material reconciliation, including quantities issued, used, rejected, returned, and destroyed, as applicable.
• Monitor packaging operations to prevent product mix-ups, labeling errors, cross-contamination, and other potential quality risks.
• Verify compliance with established procedures for packaging material segregation, traceability, and inventory control.
• Support investigations related to packaging material discrepancies, labeling errors, reconciliation differences, and packaging defects.

Batch Record Review & Documentation Compliance
• Review packaging batch records, electronic records, equipment logbooks, line clearance documentation, and associated quality records for accuracy, completeness, and GMP compliance.
• Verify adherence to Good Documentation Practices (GDP) and applicable data integrity requirements.
• Identify documentation discrepancies, missing information, and procedural inconsistencies, coordinating timely resolution with Packaging Operations.
• Support packaging batch record reconciliation and documentation review activities associated with batch disposition.
• Ensure packaging documentation accurately reflects executed operations, material usage, equipment status, and required quality verifications.

Deviations, Investigations & CAPA
• Support the identification, documentation, and investigation of packaging deviations, nonconformances, labeling discrepancies, and quality events.
• Collaborate with Packaging Operations and technical teams to evaluate potential product quality impacts and determine appropriate containment actions.
• Participate in root cause investigations involving packaging equipment, materials, procedures, personnel practices, and process execution.
• Review and support the implementation of Corrective and Preventive Actions (CAPA) addressing packaging-related quality issues.
• Monitor corrective action effectiveness and support timely closure of investigations and quality events.
• Provide QA input regarding packaging discrepancies, procedural deviations, and potential compliance risks.

Change Control & Quality Systems
• Support the evaluation and implementation of change controls affecting packaging processes, equipment, materials, labeling, and operational procedures.
• Review proposed changes to assess potential impacts on product quality, pack