Job Title
QC Microbiology Supervisor
Location
Cork, Ireland. Fully on-site.
Job Summary
The QC Microbiology Supervisor is responsible for overseeing day-to-day microbiology laboratory operations to ensure the highest standards of quality, compliance, and data integrity. This role provides technical leadership, supervises QC Microbiology analysts, and ensures microbiological testing activities comply with EU GMP, ISO 17025, ISO 22716, and internal quality systems. The Supervisor plays a key role in continuous improvement, regulatory readiness, and fostering a strong Right First Time (RFT) culture within the laboratory.
Key Responsibilities
Technical & Operational Responsibilities
- Ensure microbiology testing activities comply with GMP, GLP, GDP, EU GMP, ISO 17025, ISO 22716, and internal quality systems.
- Oversee and perform routine and non-routine microbiological testing of raw materials, in-process samples, finished products, and environmental monitoring samples.
- Review, approve, trend, and interpret microbiological data, test results, and laboratory documentation prior to release.
- Support and lead investigations, deviations, non-conformances, and CAPA related to microbiology testing, including OOS and OOT results.
- Oversee qualification, calibration, and maintenance of microbiology laboratory equipment, utilities, and controlled environments.
- Support method development, validation, verification, and method transfer activities for microbiological methods.
- Promote a strong Right First Time (RFT), data integrity, contamination control, and quality culture within the microbiology laboratory.
Documentation & Continuous Improvement
- Author, review, and approve QC Microbiology SOPs, test methods, and controlled documentation.
- Ensure microbiology laboratory documentation is accurate, complete, compliant, and inspection-ready.
- Identify and drive continuous improvement initiatives to enhance efficiency, compliance, and robustness of microbiology laboratory operations.
People Management & Leadership
- Supervise, coach, and mentor QC Microbiology analysts.
- Plan daily work allocation, shift schedules, and holiday coverage to ensure uninterrupted microbiology laboratory operations.
- Manage performance, training, competency, and authorization of analysts.
- Foster a collaborative, high-performance, and safety-focused team environment.
Cross-Functional Collaboration
- Collaborate with QC Chemistry, QC Validation, QA, Production, Engineering, R&D, and Regulatory Affairs to support site objectives, contamination control strategies, and testing demands.
Qualifications
Education & Experience
- Bachelor's degree in Microbiology, Biology, Biotechnology, or a related scientific discipline (Master's degree desirable).
- Minimum of 8 years' experience in a Quality Control microbiology laboratory environment with increasing levels of responsibility.
- Demonstrated experience working within EU GMP, ISO/IEC 17025, ISO 22716, and controlled documentation systems.
- Experience using laboratory informatics systems such as LIMS, QMS, and microbiology-related electronic systems.
- Experience supporting QC activities in regulated manufacturing environments such as cosmetics, food, dietary supplements, pharmaceuticals, or similar industries.
