• Posted on: Jan 24, 2022
  • Location: Cincinnati, OH
  • Job ID: 03e1420e
  • Type: Full Time
  • Posted on: Jan 24, 2022
  • Location: Cincinnati, OH
  • Job ID: 03e1420e
  • Type: Full Time

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Position Summary:

QC Analyst III/IV must have broad knowledge of all the 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, data entry and occasional review of data for finished product, in-process samples, stability samples, clinical materials and raw material release in a cGMP regulated environment

 

Major 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
  • If required, must be able to perform cGMP biological testing (bioassays, flow cytometry, qPCR, and ELISA)
  • Review and data entry for testing results following GMP regulations into the electronic data management systems
  • Perform laboratory investigations for out of specification and/or out of trend results
  • Write change controls and work orders for systems and instrumentation changes
  • Creation/Revision of SOP’s, and other documents required to support testing and ensure compliance
  • Participate in non-routine projects, validations and method development to meet departmental and individual goals
  • The employee will be required to participate in an on call schedule for various shift, holiday, or weekend work as needed.

Preferred Qualifications:

  • Experience with the execution of test methods for sterile and non-sterile drug products, raw materials, components and in-process testing. This includes the methods described in USP Chapters 61, 62, 71, 85, 788 and relevant informational chapters
  • 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
  • Understand common microbiological test instrumentation
  • Excellent organizational, planning and scheduling skills
  • Good verbal and written communication skills
  • Experience of Thermo Sample Manager LIMS or other applicable LIMS systems
  • The successful employee will have the ability to function in a microbiological laboratory environment; the employee should have no inhibitions regarding safely handling microorganisms present in the laboratory, aseptic gowning, and no health conditions that would prevent them from doing so
  • Optional: Hands on experience in flow cytometry, quantitative PCR, and other bioanalytical methods like ELISA is an added advantage

Education and Experience:

  • Bachelor’s in science, preferably in Biology / Microbiology / Biotechnology or Biochemistry, required
  • For QC Analyst III role, 3+ year experiecnce in pharmaceutical manufacturing or contract testing laboratory required
  • For QC Analyst IV role, 5+ year experience in pharmaceutical manufacturing or contract testing laboratory required
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