Immediate need for a Microbiologist III in Brea, CA who possess:

• 4-6 years experience, biopharma

• QC pharma environment experience

• experience doing sterality testing, endotoxin testing Bioburden.

• SOP writing knowledge and technical writing skills.

Key responsibilities include:

• This includes operation of the Autoclave, Sterilization-in-Place, Vaporized Hydrogen Peroxide.

• Minimum of Bachelor of Science degree in Microbiology or related Biological Science, or equivalents combination of education and experience.

• Provide support to the manufacturing/operations department through aseptic process simulations, bacterial retention studies, container closure integrity, SIP verifications.

• Required knowledge of Microbiology subject matter, FDA cGMP, ISO, and USP requirements.

• Testing includes: Microbial Enumeration, Endotoxin, Specified Microorganisms, Sterility Testing, TOC, Endotoxin, and Bioburden testing of High Purity water samples per USP requirements Coordinate sample submission to third party contract testing facilities.

• Prefer experience in Quality Control/Quality Assurance of sterile drug products produced by aseptic processing.

• Strict adherence to procedures and practices according to FDA regulations & strong emphasis on documentation according to cGMP/cGLP requirements.

• Coordinate and schedule equipment and instrument maintenance or calibration activities

For immediate considerations please email your resume to admin@snapstaffing.com