The In-Process Quality Assurance (IPQA) Specialist is responsible for providing real-time quality oversight of manufacturing operations to ensure sterile injectable pharmaceutical products are manufactured in compliance with current Good Manufacturing Practices (cGMP), approved procedures, batch manufacturing records, regulatory requirements, and quality standards. This role serves as the primary quality representative on the manufacturing floor, ensuring product quality, process compliance, and timely resolution of quality issues throughout production.
Senior Manager, Quality Assurance Key Responsibilities Perform routine in-process quality assurance inspections throughout manufacturing operations. Provide QA oversight during all critical manufacturing activities, including: Material dispensing Compounding Sterile filtration Aseptic filling Stoppering and capping Lyophilization Visual inspection Packaging operations Conduct line clearance prior to manufacturing and packaging activities. Verify equipment cleanliness, calibration status, and readiness before production. Review manufacturing documentation for accuracy, completeness, and compliance. Ensure manufacturing activities adhere to approved Batch Manufacturing Records (BMRs), Batch Packaging Records (BPRs), Standard Operating Procedures (SOPs), and cGMP requirements. Perform in-process sampling in accordance with approved procedures. Monitor critical process parameters and verify compliance with established specifications. Verify environmental monitoring activities are completed according to schedule and procedures. Conduct routine GMP inspections of manufacturing and production areas. Identify, document, and report deviations, non-conformances, and quality events. Participate in deviation investigations, root cause analyses, and implementation of Corrective and Preventive Actions (CAPA). Review equipment logbooks, production records, and supporting documentation for completeness and accuracy. Verify proper status labeling, material identification, and equipment identification throughout manufacturing operations. Support media fills, process validations, equipment qualifications, engineering batches, and other validation activities. Ensure compliance with gowning requirements and aseptic manufacturing techniques. Escalate quality concerns promptly and recommend appropriate corrective actions. Support internal audits, customer audits, and regulatory inspections. Promote continuous improvement initiatives and maintain GMP compliance throughout manufacturing operations. Perform investigations related to manufacturing deviations and Out-of-Specification (OOS) results. Review executed Batch Manufacturing Records (BMRs) and Batch Packaging Records (BPRs) and support batch disposition and release activities. Review audit trails for manufacturing equipment and electronic systems to ensure data integrity and regulatory compliance. Qualifications Education Bachelor's degree in Pharmacy, Chemistry, Biotechnology, Microbiology, or another related life sciences discipline. Experience Minimum of 5-10 years of Quality Assurance or In-Process Quality Assurance experience within the pharmaceutical industry. Hands-on experience in sterile injectable manufacturing is required. Demonstrated experience supporting aseptic processing operations in a GMP-regulated environment. Knowledge, Skills & Competencies Strong knowledge of current Good Manufacturing Practices (cGMP). Working knowledge of
FDA 21 CFR
Parts 210 and 211. Familiarity with EU GMP Annex 1 requirements. Knowledge of aseptic manufacturing processes and contamination control strategies. Experience with batch record review and documentation practices. Line clearance and in-process inspection expertise. Understanding of environmental monitoring programs. Knowledge of data integrity principles (ALCOA+). Experience conducting deviation investigations and supporting CAPA implementation. Strong understanding of Good Documentation Practices (GDP). Excellent attention to detail and observational skills. Strong analytical, problem-solving, and decision-making abilities. Effective written and verbal communication skills. Ability to work collaboratively with Manufacturing, Quality Control, Validation, Engineering, and other cross-functional teams. Ability to work in cleanroom environments while following gowning and aseptic requirements. Working Environment Manufacturing and cleanroom environment requiring adherence to gowning procedures and aseptic practices. May require standing, walking, and frequent presence on the production floor for extended periods. Flexibility to support multiple shifts, weekends, or production schedules as needed.
