Microbiologist
Kelly Services - San Diego, CA

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Our client, a leading biotechnology company, is seeking a Microbiologist to join their team.

Description:

Employee will perform in-process and product release testing supporting operations. Additional support duties will include laboratory maintenance, supply maintenance and ordering, data entry and review, investigation support, and area-specific projects.

Responsibilites
General laboratory duties including but not limited to:
-Sample receipt and documentation
-Pipette calibration
-Controlled temperature unit(s) monitoring
-Supplies restock
-Biohazardous waste decontamination (autoclave)
-Inspectional readiness
-Worklists generation and data entry into Laboratory Information Systems (LIMS)
-SOP review, use and training via SAP access

Testing of in-process, finished product, and stability samples utilizing the following techniques and methods:
-Total Microbial Count (USP water testing)
-Bacterial Endotoxins (USP water testing)
-Aseptic sample processing and bioburden analysis
-Growth Promotion of culture media
-Culture isolation and preliminary identification via Gram Staining
-Microbial identification (bacteria, yeast and molds)
-Visual observations of microbial growth in solutions
-Reagent preparation and serial dilutions
-Test animal observations (guinea pig and mouse)
-Primary analyst role in the Relative Potency Test and General Safety (vaccination and challenge techniques)
-Tissue culture maintenance
-Cell based potency testing (Toxin Neutralization Assay)

Quality Systems:
-Quality Notifications (deviations) in SAP
-Deviation writing
-SOP revisions
-CAPA initiation and execution
-Review and approve laboratory raw data (including LIMS)
The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned.

Education, Experience & Skills
-BS Microbiology or closely related field. Minimum of 4 years work experience in a laboratory setting.
-Basic microbiological skills (e.g. microbiological identification methods, and aseptic techniques) and previous experience with EM sample collection, water sample collection, and aseptic gowning for environmentally controlled manufacturing areas is highly desired.
-Previous work experience with sound knowledge of the functions and expectations of a QC Microbiology Laboratory in parenteral drug manufacturing and proficiency in Good Manufacturing Practices in an FDA regulated manufacturing facility is highly desired.
-Previous experience with Laboratory Information Management Systems is highly desired. Proficiency in MS Office products or comparable word processing and spreadsheet skills are required

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Kelly Services, Inc. (Kelly) is a global temporary staffing provider operating in 36 countries and territories throughout the world. The...