Laboratory Quality Assurance Specialist

Key Responsibility:

1. Laboratory QA Oversight – Chemical and Microbiology Provide QA oversight of Chemical QC and Microbiology QC laboratory activities in a sterile injectable manufacturing facility. Review and approve analytical data, raw data, test reports, and Certificates of Analysis (Co. As) for raw materials, in-process samples, finished products, and stability studies. Review analytical data generated using HPLC, FTIR, UV-Vis, Liquid Particle Counters, and other laboratory instruments, including chromatograms, spectra, calculations, and audit trails. Review microbiological testing data, including sterility, bacterial endotoxins, bioburden, microbial identification, growth promotion, and other applicable microbiological tests.
2. Environmental and Personnel Monitoring Prepare and review risk assessments, environmental monitoring (EM) plans, personnel monitoring (PM) plans, sampling locations, and monitoring frequencies. Review and trend viable and nonviable monitoring data, microbial recoveries, and alert/action limit excursions. Evaluate adverse trends, assess potential product quality impacts, and ensure appropriate investigations and CAPAs. Support contamination control and sterility assurance initiatives for aseptic manufacturing operations.
3. Laboratory Quality Systems and Investigations Review laboratory deviations, OOS/OOT results, atypical results, and data integrity issues. Ensure appropriate root cause analysis and CAPA implementation. Review and approve laboratory SOPs, specifications, analytical method validation/verification protocols, method transfer reports, and stability documentation. Review laboratory trends and support batch disposition, product quality assessments, and Annual Product Quality Reviews (APQRs).
4. Laboratory Equipment and Analytical Methods Review qualification, calibration, maintenance, and performance records for HPLC, FTIR, UV-Vis, Liquid Particle Counters, and other laboratory equipment. Ensure analytical methods are validated or verified, as applicable, and suitable for their intended use. Assess the impact of instrument failures, calibration issues, and analytical errors on laboratory results and product quality.
5. Audits and Regulatory Compliance Plan and conduct internal audits and laboratory self-inspections to assess compliance with cGMP, data integrity, and internal procedures. Conduct or support contract testing laboratory audits, review audit findings, and ensure timely CAPA closure and effectiveness verification. Support US FDA, state regulatory, and customer inspections, including laboratory readiness, documentation, and responses to observations. Ensure compliance with applicable US FDA regulations, USP standards, and pharmaceutical quality requirements. Key Skills and Competencies: In-depth knowledge of Quality Control in sterile injectable manufacturing processes. Experience of laboratory oversight for chemical and microbiology. Strong analytical and problem-solving skills. Effective communication and documentation skills. Ability to manage cross-functional teams and prioritize tasks.

Education

Bachelor’s/Master’s degree in Pharmacy, Science, Biotechnology, Microbiology, or related field.