Microbiologist (Brea, CA)

SNAPSHOT!

Are you looking for an exciting career opportunity with a technology-based special pharmaceutical company focused on the development and commercialization of therapeutic injectable drugs? THEN READ ON! Our client has a full array of expertise, including advanced scientific research in the area of drug delivery systems, process development, patent analysis, and regulatory compliance!

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

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

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

• Capable of working independently with minimum input from management.

• Strong organizational and time-management skills with the ability to make structured decisions on a routine basis.

• Must be proactive, results oriented, and have strong attention to detail.

• Strong interpersonal skills with the ability to interact with all departments at all levels in a team environment.

• Ability to effectively prioritize and manage multiple tasks to meet targeted deadlines.

• Computer literacy with proficiency in MS Office (Outlook, Word, Excel, PowerPoint).

Key responsibilities include:

• Perform bioburden and endotoxin testing of raw material, in-process, and final product to verify that material comply to specification limits. Testing includes: Microbial Enumeration, Endotoxin, Specified Microorganisms, Sterility Testing.

• Coordinate sample submission to third party contract testing facilities.

• Coordinate and schedule equipment and instrument maintenance or calibration activities.

• Support in the development, optimization, and validation of microbiological test methods.

• Generate protocols, review data, and write final reports.

• Support in the investigation process of OOS or Deviation occurrences to determine root cause.

• Participate in validation testing activities involving aseptic processes. This includes operation of the Autoclave, Sterilization-in-Place, Vaporized Hydrogen Peroxide.

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

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