The In-Process Quality Assurance (IPQA) Specialist provides real-time quality oversight for sterile injectable manufacturing operations, ensuring that all activities comply with current Good Manufacturing Practices (cGMP), approved procedures, regulatory requirements, and internal quality standards. This role focuses on shop-floor quality assurance, including in-process inspections, batch record review, deviation investigations, and aseptic processing oversight, to support the consistent production of safe, high-quality sterile pharmaceutical products.

• Provide real-time quality oversight across sterile injectable manufacturing operations, ensuring strict adherence to cGMP, Standard Operating Procedures (SOPs), and approved Batch Manufacturing Records (BMRs).
• Perform routine in-process quality inspections on the manufacturing floor to verify that production activities meet defined quality standards and specifications.
• Provide quality assurance oversight during material dispensing, ensuring correct materials, quantities, and labeling are used according to approved documentation.
• Oversee compounding activities to confirm compliance with procedures, correct sequencing of steps, and accurate documentation of process parameters.
• Monitor sterile filtration operations to ensure filters, equipment, and processes meet validated requirements and are documented appropriately.
• Provide QA oversight during aseptic filling operations, verifying adherence to aseptic techniques, environmental controls, and process parameters.
• Oversee vial or container sealing and capping operations to ensure container closure integrity and compliance with defined specifications.
• Support lyophilization activities by verifying equipment readiness, cycle parameters, and documentation of critical steps.
• Monitor visual inspection activities for filled and finished product to ensure defects are identified, classified, and documented according to procedures.
• Provide QA oversight during packaging operations, confirming correct components, labels, and coding are used and documented accurately.
• Conduct line clearance activities prior to manufacturing and packaging processes to ensure removal of previous materials, components, and documents, preventing mix-ups and cross-contamination.
• Verify equipment cleanliness, calibration status, and readiness for use before production, ensuring all equipment meets qualification and maintenance requirements.
• Perform in-process sampling according to established procedures and verify that samples are collected, labeled, and handled in compliance with quality and regulatory expectations.
• Monitor critical process parameters during manufacturing and confirm that operations remain within approved specifications, escalating issues when deviations occur.
• Review manufacturing documentation, logbooks, and production records for accuracy, completeness, and regulatory compliance, identifying and correcting gaps or errors.
• Verify material, equipment, and status labeling throughout production to ensure accurate identification and traceability at all stages of manufacturing.
• Review executed Batch Manufacturing Records (BMRs) and Batch Production Records (BPRs) for completeness, correctness, and compliance prior to batch disposition.
• Assist with batch disposition and release activities by providing quality input, supporting documentation review, and confirming resolution of quality events.
• Conduct audit trail reviews for manufacturing equipment and computerized systems to ensure data integrity and compliance with internal and regulatory expectations.
• Identify, document, and escalate deviations, nonconformances, and quality events observed during manufacturing and packaging activities.
• Support investigations related to deviations, out-of-specification (OOS) results, and manufacturing events by gathering data, reviewing records, and contributing to root cause analysis.
• Participate in the development and implementation of Corrective and Preventive Actions (CAPA) to address identified root causes and prevent recurrence of quality issues.
• Ensure consistent adherence to Good Documentation Practices (GDP) and Data Integrity principles (ALCOA+) across all manufacturing and quality records.
• Verify that environmental monitoring activities are performed according to schedule and that results are reviewed and addressed as needed.
• Ensure compliance with aseptic techniques and gowning procedures, reinforcing best practices and intervening when noncompliance is observed.
• Support media fills, validation activities, engineering batches, and equipment qu