QC Microbiologist III/IV

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