Senior specialist QC Microbio

Overview The QC Microbiology Senior Specialist is responsible for the coordination, oversight, and execution of QC Microbiology activities supporting the release of Drug Substance (DS), Drug Product (DP), In-Process Controls (IPC), Environmental Monitoring (EM), Utility Monitoring, and microbiological testing performed at the QC Bioplant. The QC Microbiology Senior Specialist ensures the compliant planning, execution, review, approval, and reporting of microbiological activities in accordance with GMP requirements and defined timelines. He/She acts as the subject matter expert (SME) for microbiological methods and testing, including Bioburden, Endotoxin (LAL), Sterility Testing, Environmental Monitoring, Utilities Monitoring, and microbiological method verification, validation, and transfer activities. The QC Microbiology Senior Specialist serves as the primary point of contact for Quality Assurance, Manufacturing, Supply Chain, Engineering, Validation, Warehouse, External Laboratories, and other Quality Control functions for the microbiological activities under his/her responsibility. In addition, the QC Microbiology Senior Specialist owns and drives quality records (deviations, investigations, CAPAs, change controls), provides technical leadership and coaching within the laboratory, contributes to continuous improvement and automation initiatives, and supports regulatory inspections and audits.[AD1.1]

Plan, coordinate, and prioritize QC Microbiology laboratory activities to ensure timely support of production and batch release activities. Perform and/or oversee microbiological testing activities including Bioburden, Endotoxin (LAL), Sterility Testing, Environmental Monitoring, and Utilities Monitoring. Define, organize, and coordinate microbiological sampling plans and testing strategies for environmental and utility monitoring programs. Review, approve, and trend microbiological data, internal and external analytical results, ensuring compliance with GMP requirements and predefined lead times. Act as Subject Matter Expert (SME) for microbiological testing methods, specifications, method suitability, method verification, validation, and transfer activities. Lead microbiology-related implementation activities for new products, methods, equipment, and technologies, serving as the interface between Analytical Transfer & Validation and QC Microbiology. Define and maintain microbiological specifications and testing strategies in compliance with applicable Pharmacopoeias (USP, Ph. Eur., JP), regulatory expectations, and internal requirements. Own and lead quality events associated with microbiological activities, including deviations, laboratory investigations, root cause analyses, CAPAs, and change controls. Collaborate cross-functionally with QA, Manufacturing, Engineering, Validation, Supply Chain, Warehouse, and external laboratories to ensure efficient communication and issue resolution. Perform thorough review and approval of analytical documentation, raw data, calculations, laboratory records, reports, and electronic data to ensure data integrity and compliance. Author, review, approve, and maintain SOPs, Work Instructions, protocols, reports, specifications, risk assessments, and quality documentation. Support laboratory inspection readiness and actively contribute to regulatory inspections, customer audits, internal audits, and responses to observations. Monitor laboratory performance through Key Performance Indicators (KPIs), identify trends, and propose actions to improve quality, compliance, efficiency, and turnaround times. Contribute to the development, implementation, and optimization of laboratory digitalization and automation initiatives. Provide technical guidance, coaching, and training to technicians and junior laboratory staff. Support management of laboratory equipment, consumables, reagents, standards, maintenance, qualification, and calibration