QC Microbiologist III/IV

Employer
Cameron Craig Group
Location
Cincinnati, Ohio, US
Salary
Competitive
Closing date
Oct 24, 2021

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POSITION SUMMARY:

QCAnalyst III/IVmust 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

MAJORRESPONSIBILITIES:

* 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 SOPs, 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 testinglaboratory required

* For QC Analyst IVrole, 5+ yearexperience in pharmaceutical manufacturing or contract testinglaboratory required

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