Demo

Manager, QC Microbiology

EPM Scientific
Albuquerque, NM Full Time
POSTED ON 2/17/2025
AVAILABLE BEFORE 5/11/2025

Our client is urgently hiring for a critical position within the Microbiology vertical. This is a rapidly expanding organization that offers growth opportunities and stability. If interested in learning more, apply below and let's set up a time to chat!

Key Responsibilities :

  • Oversee daily operations of the Microbiology laboratory, ensuring smooth and efficient workflow.
  • Lead strategic planning efforts for the laboratory and its staff to meet organizational goals.
  • Serve as the subject matter expert on contamination control and microbiological testing of parenteral drug products.
  • Participate in customer and regulatory audits, ensuring compliance with industry standards.
  • Engage with new clients and manage client interactions related to microbiological services.
  • Attend site metrics meetings to discuss laboratory performance and key performance indicators (KPIs).
  • Contribute to site-wide improvement projects to enhance laboratory efficiency and effectiveness.
  • Manage laboratory budgeting, ensuring proper allocation of resources and cost control.
  • Review and interpret data, including protocols, investigations, and lab documentation, to ensure accuracy and compliance.
  • Oversee the entire laboratory team, providing leadership, guidance, and direction.
  • Conduct staff performance reviews, handle disciplinary actions, and ensure team members receive appropriate training and development.
  • Work independently with limited supervision while also collaborating on cross-functional teams.
  • Writes and revises Microbiology and other relevant SOP’s, as required
  • Manage staff shift schedules to ensure adequate manufacturing support.
  • Expert in CGMP guidelines, ISO 17025, and USP microbiological testing, including USP
  • Maintain and update laboratory policy and procedure manuals, assist in developing and validating procedures, and ensure proper documentation.
  • Ensure timely completion of projects, CAPAs, and investigations.
  • Review and approve environmental and microbiological test results, including those from contract labs, to support lot disposition and site priorities.
  • Oversee the review and implementation of compliance guidelines, customer projects (e.g., Method Transfer, Development), validation, and continuous improvement efforts to meet or exceed industry standards.
  • Lead cross-departmental collaboration to improve Contamination Control Strategy and Environmental Monitoring Program.
  • Represent the department in regulatory, customer, and internal audits.
  • Address audit observations and execute related CAPAs in a timely manner.
  • Develop and execute training on laboratory methods, instrumentation, and aseptic technique.
  • Build and maintain the department’s Training Matrix to align with industry standards and continuous improvement goals.

Key Qualification

  • Bachelor’s degree in a relevant discipline (biological sciences or equivalent).
  • Minimum Six (6 ) years of experience in the pharmaceutical industry within a Quality Control microbiology role.
  • Must have experience working in a cGMP environment and aseptic facility.
  • Minimum of Two (2) years of leadership experience.
  • Extensive EMPQ knowledge and experience within EMPQ protocols is a must.
  • Microbiological testing experience including method transfers and qualifications.
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