Supervisor Quality Control, Microbiology

Changing lives. Building Careers.   Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what’s possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care. Critical Prerequisites for the Position Bachelor’s degree or higher in Microbiology, Biology, Biochemistry, Life Sciences, or a related scientific discipline. Minimum seven (7) years of GMP/GLP laboratory experience within the medical device, pharmaceutical, biotechnology, or other FDA-regulated industry. Minimum two (2) years of supervisory or technical leadership experience. Strong working knowledge of FDA Quality Management System Regulation (QMSR), 21 CFR Part 820, ISO 13485, and applicable quality-system requirements. Experience with microbiological method validation, verification, transfer and investigations. Extensive hands-on experience with core microbiology laboratory systems, aseptic techniques, environmental monitoring, and culture media preparation/handling within a regulated cGMP environment. Demonstrated experience managing environmental monitoring programs, cleanroom operations, utility monitoring, and microbiological testing activities. Experience with OOS/OOT, NC, CAPA and root cause investigations. Strong understanding of laboratory data integrity principles and documentation practices. Excellent communication, technical writing, organizational, leadership, and problem-solving skills. Proficiency with Microsoft Office applications and laboratory information management systems (LIMS) or equivalent electronic systems preferred.

Summary Description The Supervisor, QC Microbiology Laboratory provides technical and operational leadership of the QC Microbiology Laboratory. Responsible for microbiological testing supporting in-process and finished product testing, environmental monitoring, utility monitoring, cleanroom qualification and microbiological validation activities. Ensures compliant laboratory operations, data integrity, testing execution, inventory control, personnel development and inspection readiness while partnering with Manufacturing, QA, Engineering, Product Development, and external laboratories. The role ensures compliance with applicable FDA regulations, ISO 13485 requirements, GMP/GLP standards, and company quality system procedures while fostering a culture of quality, compliance, and continuous improvement . Essential Duties and Responsibilities Supervise daily operations of the Quality Control Microbiology Laboratory and ensure testing activities are completed accurately and on schedule. Oversee and coordinate microbiological testing of raw materials, in-process materials, finished products, validation samples, stability samples, and special studies in support of manufacturing operations and product release. Manage and coordinate Environmental Monitoring (EM) and Utilities Monitoring programs for controlled manufacturing environments, cleanrooms, USP Purified Water systems, and compressed gas systems. Provide technical oversight of microbiological testing systems, environmental monitoring programs, contamination control activities, utility monitoring programs, and laboratory investigations. Provide leadership, coaching, mentoring, and performance management for laboratory personnel. Assign laboratory workload and establish testing priorities to support manufacturing schedules and business objectives. Ensure laboratory testing is performed in accordance with approved procedures, specifications, GMP, GLP, GDP, and applicable regulatory requirements. Review, approve, and ensure the accuracy of laboratory data, testing records, logbooks, protocols, reports, and other quality records. Manage microbiological testing performed by qualified external contract laboratories, including sample submission, testing