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Technician, Laboratory Quality Assurance

JenaValve

Job Title : Technician, Laboratory Quality Assurance


Role Level: Individual Contributor

Supervisor/Manager Title: Manager, Laboratory

Job Location & Environment: Irvine, CA - Laboratory Facility / Controlled Cleanroom Environment

Job Description Summary: The laboratory technician is responsible to support sustaining manufacturing by performing microbiological and chemistry testing on various kinds of samples and document the results to assure quality.

Job Responsibilities:
  • Comply with company's policy and procedures on maintenance of personnel hygiene and CEA cleanliness to ensure product safety.
  • Perform microbiological tests, including in-process solutions/water bioburden tests, environmental monitoring, basic microbial characterization such as gram staining.
  • Perform Chemistry testing for solutions, such as pH, concentration, and raw glutaraldehyde test.
  • Responsible for reading plates, recording the test results, and verifying test results meet the specification per standard operating procedure.
  • Responsible for sending samples to the contract lab and any sample preparation if required.
  • Perform sample collections as needed.
  • Assist with investigation for out of specification, above alert, action level results and clean room excursions.
  • Maintains lab supply inventory.
  • Responsible for general lab equipment maintenance and overall cleanliness of lab.
  • Perform additional duties as assigned by the laboratory manager.
Required Education and Experience:
  • B.S in biological science discipline or equivalent with 2 plus years in experience.
  • 2+ year experience in medical device/ pharmaceutical/ nutraceutical microbiology or sterilization and laboratory testing.
Skills and Abilities Required for This Job:
  • Good written and verbal communication skills.
  • Strong cGMP skills.
  • Demonstrate good documentation practices.
  • Knowledge of good laboratory practices and laboratory safety.
Vacancy posted 1 day ago
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