Technician, Laboratory Quality Assurance

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: