Quality Assurance Associate

Key Responsibilities and Duties Provide Quality Assurance (QA) and regulatory compliance support to Production, Quality Control (QC), Materials Management, and other GMP-regulated functional areas to ensure adherence to current Good Manufacturing Practices (cGMP), applicable regulatory requirements, established Standard Operating Procedures (SOPs), and internal quality policies. Initiate, author, and manage Non-Conformance Reports (NCRs), as assigned, including conducting investigations, identifying root causes, and developing, assigning, and implementing appropriate Corrective and Preventive Actions (CAPAs). Collaborate with cross-functional teams to ensure thorough investigations, effective root cause analysis, and appropriate corrective and preventive actions. Monitor and track investigations and CAPAs to ensure timely completion, review supporting documentation, verify effectiveness and completion, and submit records for management approval and closure. Generate Quality Management System (QMS) metrics and prepare periodic trend analyses for non-conformances, CAPAs, change controls, and other quality-related activities. Identify recurring trends and potential areas for quality improvement. Perform production line-opening and line-closing activities in accordance with approved procedures, established instructions, and GMP requirements. Conduct Quality Control laboratory audits and assessments, as assigned, to evaluate compliance with cGMP requirements, approved procedures, and internal quality standards. Review and approve GMP-related documents and records, including change controls, SOPs, analytical test methods, specifications, Batch Manufacturing Records (BMRs), and Packaging Batch Records (PBRs), ensuring accuracy, completeness, and compliance prior to finished product release. Assist in the development, review, and execution of cleaning validation protocols and reports. Collaborate with Production to identify worst-case product-contact locations and establish appropriate sampling sites for cleaning validation swabbing activities. Manage and oversee the Environmental Monitoring (EM) Program, including reviewing and approving environmental monitoring data, evaluating results against established acceptance criteria, investigating excursions, and performing periodic trend analysis. Prepare, review, and approve Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols and reports for equipment, utilities, and automation systems, as assigned. Coordinate with relevant departments to ensure appropriate qualification documentation and maintain equipment and system lifecycle records, including User Requirement Specifications (URS), Functional Requirement Specifications (FRS), Factory Acceptance Testing (FAT), and Site Acceptance Testing (SAT), as applicable. Coordinate equipment, utility, and facility qualification and validation projects to ensure completion within established timelines. Liaise with internal stakeholders to plan and schedule qualification activities and, when required, identify qualified external contractors, obtain quotations, and coordinate contractual arrangements. Conduct internal GMP audits of applicable functional areas to assess compliance with regulatory requirements and internal quality standards. Document audit observations, issue findings, and monitor corrective actions to ensure timely and effective resolution. Perform post-market Quality Assurance activities, including the preparation and review of Annual Product Quality Reviews (APQRs), as well as the investigation and assessment of market complaints involving distributed batches. Establish, implement, and maintain systems for the effective management, control, retention, and retrieval of GMP-related data, documents, and quality records. Develop, review, and revise departmental SOPs and other controlled documents to ensure continued compliance with cGMP requirements, applicable regulatory standard…

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