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Associate Director, Microbiology

Employer
Akorn, Inc
Location
Somerset, New Jersey, US
Salary
Competitive
Closing date
Oct 31, 2021

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Sector
Consultancy/Private Sector
Field
Conservation science
Discipline
Biology
Salary Type
Salary
Employment Type
Full time
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Manages, plans, coordinates, directs, and evaluates all activities associated with the Microbiology Department. Ensures microbiological testing is performed and in compliance with USP, FDA regulations, guides, guidelines, ICH, ISO, and other regulatory requirements. Manage, direct, and mentor QC Microbiology staff.
  • Responsible for overseeing all functions as performed by the Microbiology Laboratory, microbiological testing, environmental monitoring and Aseptic Core Monitors.
  • Drafts, reviews, updates and approves laboratory Quality Systems, validations, test methods, specifications, and SOPs.
  • Oversees the review of laboratory logbooks, notebooks, and documentation as it pertains to the Microbiology Laboratory.
  • Oversees and/or purchases laboratory equipment and necessary supplies for the laboratory.
  • Investigates sterility test positives and "Out of Specification" (OOS) occurrences according to company procedures.
  • Oversees the site environmental monitoring program including the Aseptic Core Monitors
  • Responsible for cGMP compliance and continuous quality improvement in the laboratory.
  • Develop and revise as necessary, a Microbiology organization structure that is efficient and supports the business needs under management guidance.
  • Recruit, develop, train, and mentor staff such that they have the education, training, experience, or any combination thereof to perform their job functions. This includes succession planning.
  • Oversees and releases sterility, biological indicator, bioburden, and environmental tests.
  • Directly supervises Supervisors of Microbiology laboratories/environmental monitors and Aseptic Core Monitors covering 3 shifts 5 days per week
  • Has an understanding and knowledge of the following:
  • Sterility Testing by Membrane Filtration, Direct Inoculation, Anti-Microbials, identification of organisms, use of disinfectants and lethality studies
  • Bacteriostasis/Fungistasis Testing and Population Determination and testing of Biological Indicators
  • Bioburden determination of Formulated Product,
  • Total Heterotrophic Plate Count of City Water and Process Water
  • Preparation, Sterilization, Incubation, and Growth Promotion of culture media
  • Bacterial Endotoxin Testing, Verification of Lysate Sensitivity, and Certification of Endotoxin Potency
  • Microbial Limit Testing
  • Antibiotic Microbial Assays for Potency Determination
  • Preservative Effectiveness Testing
  • Container Closure Integrity Testing
  • Environmental Monitoring Programs including the use of Contact Plates, Settling Plates, and Air Samplers.
  • Operation and validation of autoclaves and dry heat ovens
  • Temperature mapping of Incubators, refrigerators
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