Microbiology Quality Control Associate Expert

6 days ago


East Hanover, New Jersey, United States Novartis Group Companies Full time
Job Description

Job Summary:

We are seeking a highly skilled QC Associate Expert Microbiology to join our team at Novartis Group Companies. As a key member of our Quality Control department, you will be responsible for performing microbiology/EM testing and other activities to support our clinical release strategies.

Key Responsibilities:

  • Perform micro/EM testing in support of clinical release strategies.
  • Perform all testing and activities compliantly following appropriate SOPs and procedures.
  • Maintain controls and reference standards to support testing.
  • Execute and follow SOPs, WPs, and quality policies and peer review and archive analytical data in lab documentation systems.
  • Support monthly/quarterly laboratory cleaning.
  • Manage reagent/consumable inventory and equipment cleaning for assigned areas of responsibilities.
  • Ensure cleanliness of laboratory working areas, support and author OOS/OOE/OOT and deviation investigations.
  • Participate in CAPA implementation in a timely manner and follow GxP quality policies and procedures.
  • Ensure all assigned training is completed within required time frame.
  • Support 5S and Lean projects, identify process improvements.
  • Knowledge of LabWare, LIMS and/or other QC data systems and appropriate GMP/GLP quality systems (e.g., ESOPs, Trackwise, BMRAM, etc.).
  • Support execution method qualification/optimization of methods.
  • Interface with regulatory agencies during audits as required.
  • In addition to these primary duties, provide coverage for all appropriate areas.
  • Contributes to assigned projects by following predefined tasks and executing as instructed.
  • Perform other job duties as assigned.

Requirements:

  • Bachelor's degree in biology, chemistry, biochemistry, microbiology or other related area. MS is preferred.
  • At least 1 year of relevant experience in the pharmaceutical, biologics, microbiology, sterile manufacture, medical device industry or related industry.
  • Thorough knowledge of microbiological and environmental monitoring, test methods is required.
  • Ability to communicate clearly with a variety of individuals in various aspects of Novartis operations.
  • Detail-oriented with expertise in problem solving and solid decision-making abilities.
  • Strong interpersonal skills which include a professional demeanor when interacting with Novartis personnel.
  • Strong written and verbal communication skills are essential.

Desired Requirements:

  • Knowledge of cGMP and an understanding of the concepts of GLP, good clinical practices and FDA guidelines, applicable state and foreign regulations, and standards routinely used in the industry (i.e., ANSI, ISO, etc.).
  • Micro/Environmental knowledge to facilitate investigations is preferred.
  • Knowledge of LIMS systems is preferred.

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