QA Officer

The QA Officer will provide routine shop floor and operational QA support with a primary focus on:

• Issuance, control, reconciliation, and accountability of GMP labels.
• Verification of label requests against approved documentation and production schedules.
• Review of completed label issuance records and investigation of discrepancies.
• Operational and Aseptic Processing (AP/APS) batch record review to ensure accuracy, completeness, and compliance with GMP requirements.
• Review and approval of manufacturing documentation, including batch records, logbooks, and supporting records.
• Identification, documentation, and escalation of documentation errors, deviations, and GMP concerns.
• Support of batch disposition activities through timely completion of QA documentation reviews.
• Participation in shop floor quality oversight activities and routine GMP monitoring.
• Collaboration with Manufacturing, Warehouse, and Quality Systems teams to resolve documentation and compliance issues.
• Support inspections, audits, and regulatory commitments related to documentation and label control processes.

Primary focus.

• Approximately 50-60%: Label issuance, reconciliation, and label control activities.
• Approximately 30-40%: Operational and APS batch record review.
• Approximately 10-20%: Shop floor QA support, investigations, and continuous improvement activities.