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. This position includes:

• 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. Monitors lab supply costs and looks for ways to work with suppliers to reduce consumables cost when appropriate. Consults with management, when appropriate, about laboratory supply variances. Demonstrates the ability to assess upcoming laboratory supply needs and prepare accordingly. Makes realistic and actionable plans to address supply chain issues. Demonstrates the ability to use available tools and technologies to track laboratory supply expenditures and usage. Coordinates efforts with suppliers to ensure inventory replenishment and avoid expiry.
• Keeps management informed anytime laboratory supplies or externally provided services exceed budget projections. Analyzes laboratory supply usage patterns to anticipate upcoming needs. Maintains the QC department ordering system to reduce costs and waste due to expiry. Keeps current on physical and computerized tracking systems for materials and supplies.
• 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. Create and maintain relevant metrics for department/site.
  • Spreadsheets and databases will be leveraged for departmental and company metrics, presentations, and data/testing tracking/verification. The QC Microbiology/EM Laboratory Manager is involved in making key decisions for the Microbiology and EM laboratories, projects, and resource allocation/scheduling.
  • Manages and develops personnel.
  • Cascades relevant information.
  • Inspires and motivates to achieve top performance.
  • Inspires and promotes employee growth and development within the team.
  • 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 and is answerable to Leadership.
  • Provides appropriate team support in cross-function activities (e.g., method transfers, method validations, cross-functional projects, and audits such as MDSAP, FDA, ISO, customer, and internal inspections/audits).
• Testing
  • Ensures timely and efficient scheduling of raw material, intermediates, environmental monitoring, and finished goods testing requests submitted to the Microbiology and EM laboratories. Ability to perform routine testing of samples submitted to the laboratory as appropriate. Schedules and participates in cleaning, inventory, and maintenance tasks in the lab.
  • Works collaboratively with other QC department managers to ensure the testing and services provided to the site are developed, tested, and delivered according to established procedures and regulations.
  • Accountable for inventory management and ordering/stocking of all QC department laboratory supplies.
  • Ensures laboratory equipment is in compliance with procedures and GLP requirements. The QC Microbiology/EM Laboratory Manager is responsible for making sure all testing is performed on laboratory instrumentation that are appropriately validated, calibrated, and monitored for compliance.
  • Troubleshoots laboratory issues related to assays, methods, instruments, and equipment. Recommends potential corrective and/or preventive actions and implements these actions within the laboratory.
  • Performs GMP review of test data to ensure that test results meet all specifications. Trends data and analyzes trends to proactively mitigate equipment and reagent performance issues. Verifies laboratory equipment and associated equipment logs to ensure proper operation.
• Laboratory Supplies
  • Oversees the management of QC department laboratory supplies/consumables.
  • Ensures the Kanban system for ordering is maintained.
  • Researches alternative suppliers for high volume and/or critical supplies to make sure supply chain issues do not impact/disrupt laboratory testing schedule adherence.
  • Monitors the QC department laboratory supplies budget and proactively communicates issues that affect budget adherence.
• Quality
  • The QC Microbiology/EM Laboratory Manager is accountable for communicating, explaining, and maintaining internal quality standards for QC department deliverables, projects, and documentation. They are responsible for the functioning of the Microbiology and EM laboratories in compliance with SOPs, GLP, GMP, and HSE requirements.
  • Ensures all laboratory testing documentation is completed in an accurate, thorough, and timely manner. Documents test results in compliance with procedures and GDP requirements.
  • Performs regular self-audits of the Microbiology and EM laboratory areas (including storage areas) and assists/leads activities to address audit findings.
  • Executes laboratory, non-conformance, and CAPA investigations in compliance with procedures. Provides input for laboratory investigations and documents invalid test results as appropriate.
• Documentation/Training
  • Trains and mentors laboratory personnel on Microbiology and EM laboratory techniques, testing, documentation, data entry, processes, and procedures. Responsible for making sure the overall team training is maintained to current department processes and procedures.
  • Verifies the entry of data into electronic systems (LIMS) by laboratory personnel is performed in a timely, accurate, and efficient manner. Ensures laboratory personnel assist with LIMS data entry as required to support LIMS maintenance and validation activities.
  • Authors new standard operating procedures (SOPs) and performs SOP revisions to existing QC department SOPs. Facilitates SOP implementation and training.
  • Performs regular reviews of laboratory paper-based testing documentation and data entry into electronic systems (LIMS) to confirm compliance with procedures, GLP, and GDP requirements.
• Safety
  • Ensures the team complies with all safety policies and procedures at all times.
  • Appropriately utilizes PPE (Personal Protective Equipment) as required to perform routine and non-routine laboratory duties.
  • Performs safety audits of the laboratory and assists/leads activities to address audit findings. It is an expectation that the QC Microbiology/EM Laboratory Manager facilitates the identification and implementation of initiatives for increasing laboratory compliance, safety, and efficiency.
• Continuous Improvement
  • Lead and promote continuous improvement through team and individual initiatives.
  • Identifies areas of deficiency and implements practices to improve employee safety, ergonomics, poor workflow/process design, etc. Recommends and implements efficiencies for process improvements which result in effective outcomes.
  • Serves on cross-functional project teams to increase QC testing quality, decrease operational costs, and improve Microbiology/EM department efficiency/productivity.
  • Maintains all Microbiology and EM laboratory areas in a well-organized, clean, and tidy manner at all times in compliance with cGLP.
• Other Duties
  • Ensures the Microbiology/EM department works collaboratively with other departments and assists with executing validation protocols associated with Microbiology and EM laboratory equipment, associated software, and procedures including revalidation as scheduled/or required to maintain systems in a validated state.
  • Performs additional job-related duties as assigned by management.

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 3 years of supervisory experience required, GMP environment preferred.
• Experience in managing a department budget and maintaining laboratory supply inventories at a department level.
• Demonstrates in-depth technical and scientific knowledge with a working knowledge of relevant laboratory techniques and quality principles (GMP/GLP). Specific experience with microbiological/EM testing preferred.
• Experience in the use of software tools for data entry and analysis (LIMS) and proficiency working with Microsoft Office Suite (e.g., Excel, PowerPoint, Outlook, Word).
• Able to demonstrate experience in the interpretation and application of relevant Domestic and International Regulations and Industry Standards (e.g., ISO, QSR, FDA.). Has knowledge of USP and EP/BP method/validation regulations.
• Experience in supporting regulatory audits (e.g., FDA, MDSAP, ISO, OSHA, EPA).

Knowledge, Skills, and Abilities

• Strong organizational skills. Displays the ability to prioritize work and manage multiple tasks independently.
• Excellent written communication and technical writing skills. Clearly demonstrates competence in the selection and use of root cause analysis tools and techniques (e.g., 5 Whys, Pareto Analysis, 5M +E).
• Displays strong interpersonal skills and ability to work with all levels of an organization. Clearly expresses ideas (verbal and written) and demonstrates the ability to apply a quality mindset when completing Microbiology/EM laboratory tasks.
• Demonstrates the ability to read, understand, author, redline and execute standard operating procedures (SOPs).
• Displays ability to achieve BioMerieux QE investigator certifications for product/process/testing/facility issues with product and non-product impact.
• Exhibits both analytical and problem-solving skills. Proven ability to problem solve/troubleshoot and provide solutions for laboratory issues.
• Demonstrates proficiency in human resource management for the efficient and effective management of direct reports and team development.
• Able to assess safety and environmental risks to ensure laboratory tasks adhere to HSE management system.