Temp-QC Analyst-Microbiology

AlkermesWilmington, OH
86d

About The Position

QC Analyst I must have broad knowledge of microbiology techniques within the laboratory required for the routine support of the microbiology laboratory operations. In this role the Analyst will be a fully functional member of the team responsible for testing and data entry for finished product, in-process samples, stability samples, clinical materials and raw material release in a cGMP regulated environment.

Requirements

  • Bachelor's in science, preferably in Biology / Microbiology / Biotechnology or Biochemistry.
  • 1+ year experience in pharmaceutical manufacturing or contract testing laboratory preferred.
  • Experience with the execution of test methods for sterile and non-sterile drug products, raw materials, components and in-process testing.
  • Understanding of common microbiological test instrumentation.
  • Ability to function in a microbiological laboratory environment and safely handle microorganisms.

Nice To Haves

  • Critical thinker, ability to identify issues and work quickly to bring resolution.
  • Capable of managing/coordinating multiple priorities in a dynamic environment, while maintaining a professional demeanor.
  • Excellent organizational, planning and scheduling skills.
  • Good verbal and written communication skills.
  • Ability to work safely; seek out and encourage safe practices.
  • Ability to focus attention to details and ensure high quality work.
  • Self-starter that takes initiative to do work with minimal supervision.
  • Time management skills.
  • Commitment to teamwork.
  • Commitment to continuous improvement.
  • Effective communication with co-workers and supervisors.

Responsibilities

  • Execution of microbiological tests including but not limited to bioburden, LAL, growth promotion, sterility, particulate profiling and microbial identification of bulk, raw materials, in-process material, components, clinical materials and finished product.
  • Aid in laboratory investigations related to microbiology testing.
  • Participate in an on call schedule for various shift, holiday, or weekend work as needed.
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