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Laboratory Manager- Jackson MO

Posted: 09/21/2021

Full Job Description:

The Laboratory Manager is responsible for overseeing all aspects of operation for a medical device sterility laboratory. This position develops, enacts, and enforces quality controls and supporting systems to ensure that all laboratory-generated results meet or exceed client, state, and federal quality standards. Ensure the laboratory is operated in accordance with all local, state, and federal regulations governing the safe operation of a commercial laboratory.

Job Responsibilities:

  • Oversees all aspects of laboratory operations
  • Directs day to day laboratory activities of staff
  • Maintains customer and supplier relationships
  • Leads audit activities
  • Plans equipment qualification: protocols, study execution, reports
  • Develops and validates microbiological methods, including bioburden, sterility, bacterial endotoxin, and microbial identification
  • Develops, reviews, and approves SOP’s
  • Creates and reviews protocols, technical reports, data collection sheets, logbooks, and raw data
  • Maintains current knowledge of industry standards and regulatory environment
  • Plans efficient and effective workflow in the microbiology laboratory
  • Prepares for and facilitates periodic customer or regulatory audits
  • Actively participates in the strategic planning
  • Builds and maintains positive client relationships, ensures client satisfaction
  • Provides laboratory operations leadership
  • Assists in operational budgeting
  • Understands costs of testing and how to calculate them
  • Initiates advances in methodology and/or technology use
  • Performs other duties as assigned
  • Interface with and represent laboratory operations to local, state, and federal regulators as required from time to time
  • Recruits, hires, and manages laboratory staff
  • Represents the laboratory at conferences and makes presentations as required
  • Other projects as assigned

Qualifications:

  • MS or PHD in Microbiology, Chemistry, Biochemistry, Pharmacy, or related science
  • 6 to 8 years of related experience
  • Microbiology laboratory experience in medical device, pharmaceutical, or biotech industry
  • Able to use and experience with using HEPA Hoods, Stomachers, Colony Counters, Microscopes, Water Baths, Incubators, Filtration Apparatuses, Centrifuges, Vortex Mixers, Autoclaves, Balances, Pipettes
  • Trustworthy
  • Organized
  • Proficiency writing SOPs
  • cGMP
  • Problem Solver
  • Detail Oriented
  • Ability to work alone and with a team

Pay: From $100,000.00 per year

Benefits:

  • 401(k)
  • 401(k) matching
  • Dental insurance
  • Disability insurance
  • Employee assistance program
  • Health insurance
  • Life insurance
  • Paid time off
  • Tuition reimbursement
  • Vision insurance