1st shift, M-F 6AM - 2:30PM
Position Overview
The Manager of QC Microbiology is responsible for overseeing microbiology operations, personnel management, and quality compliance within the laboratory. Reporting to the Head of Quality, this role ensures operational efficiency, regulatory adherence, and continuous improvement while supporting business goals.
Key Responsibilities
- Recruit, train, and evaluate team members; schedule workflows to meet business needs.
- Provide ongoing staff development through feedback, performance reviews, and corrective actions as needed.
- Manage laboratory budgets, procure equipment and supplies, and optimize asset utilization.
- Lead equipment lifecycle management, qualification, and validation of laboratory systems and microbial methods.
- Provide technical guidance, troubleshoot issues, and drive process improvements.
- Investigate non-conformances, approve deviations, and ensure timely CAPA and batch record resolution.
- Oversee quality systems, monitor audit findings, and implement effective change controls.
- Standardize processes, execute continuous improvement projects, and promote best laboratory practices.
- Analyze and trend microbiological and environmental monitoring data, maintaining compliance with set timelines.
- Develop and track laboratory KPIs, ensuring alignment with quality and operational goals.
- Prepare and revise SOPs, work instructions, and protocols to reflect current practices.
- Participate in regulatory audits, internal reviews, and external quality assessments.
Qualifications
- Education: Bachelor's degree in Microbiology or related field; GMP experience preferred.
- Experience: 7–10 years in environmental monitoring or biopharmaceutical quality control.
- Skills: Proficiency in QC microbial testing, method validation, and regulatory compliance (e.g., 21 CFR 210/211, EU Annex 1, FDA guidance). Strong knowledge of digital systems (e.g., Microsoft Office, MODA, Visio).