732-661-0400

QC Microbiologist

  • Location: Irvine
  • Type: Contract To Hire
  • Job #33582

Seeking a mid-level Microbiologist within our Medical Device Contract Testing Laboratory to join their fast-growing team!

Position: QC Microbiologist
Location: Irvine, CA
Direct Hire Opportunity 

Job Description: 

  • Perform microbiological testing utilizing knowledge of USP, AAMI, ISO and other applicable standards or guidelines.
  • Prepare or participate in the preparation of test specifications in conjunction with the requirements of the applicable standards and/or client instructions.
  • Independently perform routine test article/product preparation and execute routine testing and perform routine calculations per SOPs, and according to applicable work instructions. 
  • Assure proper records and sufficient data are maintained on all testing and the research information.
  • Participate in the improvement of documents, test systems, quality systems and workflow.
  • Direct client contact as needed.
  • Responsible for review of incoming test articles and paperwork for appropriateness and accuracy and for taking all concerns to management as required.
  • Maintain relevant supplies, materials, and equipment used in routine testing.
  • Assure testing/test article preparation/product is performed within due dates.
  • Prepare and maintain cell lines and reagents and/or test articles as required and applicable for testing.
  • Routes all positive results or unusual testing occurrences to management.
  • Responsible for checking laboratory equipment, being on-call and respond to continuous monitoring alarms as applicable. If needed, the Associate will respond in accordance with criteria outlined in Standard Operating Procedures.
  • Perform personal gowning environmental testing, and submit organisms from gowning, environmental and sterility test positives for identification and inclusion in monthly trending data, as required for specific testing as applicable.
  • Operate autoclave, depyrogenation oven or other specified laboratory equipment as applicable.
  • Perform Kinetic-Chromogenic LAL testing as applicable.
  • Perform Environmental Monitoring, clean and disinfect cleanroom suites as applicable.
  • Other duties as assigned.

Requirements:

  • Bachelor degree and 4 years of experience is preferred.
  • Awareness of applicable guidelines and regulations including, but not limited to USP, ISO, CTFA, FSA.
  • Ability to work in GLP/GMP environment.

INDWST1

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Equal Employment Opportunity (EEO) Information

While the position you're applying for may not be for a government role, Astrix is a governmental contractor and, as such, is required to collect certain information in its applicants. Astrix is an Equal Opportunity Employer and does not discriminate against any applicant for employment, or any employee because of age, color, sex, disability, national origin, race, religion, or veteran status. Completion of these fields will not affect your opportunity for employment or the terms or conditions of your employment.

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