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 (CoAs) 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 and Qualifications:

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