Technician, Laboratory Quality Assurance

Technician, Laboratory Quality Assurance

Irvine, CA - Laboratory Facility / Controlled Cleanroom Environment

Job Title: Technician, Laboratory Quality Assurance

Role Level: Individual Contributor

Supervisor/Manager Title: Manager, Laboratory

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.

Qualifications:

• 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.

• Good written and verbal communication skills.
• Strong cGMP skills.
• Demonstrate good documentation practices.
• Knowledge of good laboratory practices and laboratory safety.