QC Microbiology/EM Laboratory Manager
Location: Durham, NC, United States
Position Type: Unfixed Term
Job Function: Quality
A world leader in the field of in vitro diagnostics for more than 60 years, bioMerieux provides diagnostic solutions which determine the source of disease and contamination to improve patient health and ensure consumer safety. In North America we have more than 6,200 team members across 11 sites or subsidiaries, including Salt Lake City-based BioFire Diagnostics and one subsidiary in Montreal, Canada. Come and join a family-owned global company with a long-term vision, and a human-centered culture.
Description
Position Summary: The QC Microbiology/EM Laboratory Manager provides direct oversight and guidance in the Quality Control Microbiology and Environmental Monitoring (EM) testing laboratories, including applicable support and storage areas, to ensure bioMerieux manufactured products are appropriately measured and monitored according to quality system requirements (e.g., QSR and ISO9001/ISO13485). This position is in a fast-paced, FDA regulated environment in the Medical Devices/Diagnostics Industry. QC Microbiology/EM Laboratory Manager is a key position with expected knowledge and comprehension of subject matter related to EM and microbiological laboratory testing. They are responsible for ensuring microbiological and EM testing is performed in compliance with procedures and GDP requirements including growth performance, antimicrobial neutralization and contamination checks, bioburden and environmental monitoring sampling/testing of water, surface, air, and cleaning. This position requires a 100% on-site presence.
- Administration of all aspects of Microbiology and EM tasks including testing, inspection, laboratory supply maintenance, scheduling, cleaning, and upkeep of laboratory equipment.
- Purchasing QC Department laboratory supplies. Makes sound, well-considered decisions to make the most of available funds and resources.
- Keeps management informed anytime laboratory supplies or externally provided services exceed budget projections.
- Development of employees in line with the site competency framework.
- Ensuring team accountability for performance, metrics, and projects.
- Effectively leading quality initiatives that improve department processes and the efficiency, reliability, and accuracy of testing.
- Ensuring a strong department quality culture and facilitating staff engagement.
Primary Responsibilities:
- Leadership
- Models the principles and behaviors of bioMerieux and ensures personnel follow the company code of conduct.
- Leads strategy implementation and sets/monitors progress of team objectives which align with company and site objectives.
- Communicate progress, status, and roadblocks as required.
- Drive projects, assignments, and complete presentations within timelines and budgets.
- Manages and develops personnel.
- Inspires and motivates to achieve top performance.
- Regularly meets 1:1 with direct reports to discuss performance, provides constructive feedback, and identifies opportunities for growth and career development.
- Interacts in a positive and professional manner with colleagues, internal departments, contractors, vendors, and consultants.
- Provides appropriate team support in cross-function activities.
- Testing
- Ensures timely and efficient scheduling of testing requests submitted to the Microbiology and EM laboratories.
- Works collaboratively with other QC department managers.
- Accountable for inventory management and ordering/stocking of all QC department laboratory supplies.
- Troubleshoots laboratory issues related to assays, methods, instruments, and equipment.
- Quality
- The QC Microbiology/EM Laboratory Manager is accountable for communicating, explaining, and maintaining internal quality standards.
- Ensures all laboratory testing documentation is completed accurately and timely.
- Executes laboratory, non-conformance, and CAPA investigations in compliance with procedures.
- Documentation/Training
- Trains and mentors laboratory personnel on Microbiology and EM laboratory techniques.
- Authors new standard operating procedures (SOPs).
- Safety
- Ensures the team complies with all safety policies and procedures at all times.
- Performs safety audits of the laboratory.
- Continuous Improvement
- Lead and promote continuous improvement through team and individual initiatives.
Education, Skills & Experience:
- Bachelor's degree with 6 years of experience in a regulated laboratory environment, Environmental Monitoring and Microbiology is highly preferred OR Masters degree with 3 years of experience in a regulated laboratory environment.
- Minimum of 1 years of supervisory experience required, GMP environment preferred.
- Experience in managing a department budget and maintaining laboratory supply inventories.
- Demonstrates in-depth technical and scientific knowledge with a working knowledge of relevant laboratory techniques and quality principles (GMP/GLP).
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