Senior Technician, Laboratory Quality Assurance

Job Title: Senior Technician, Laboratory Quality Assurance

Supervisor/Manager Title: Manager, Laboratory

Job Description Summary: The Senior Laboratory QA Technician is responsible to support sustaining manufacturing and special project by performing microbiological and chemistry testing on various kinds of samples and maintain documentation.

Job Responsibilities:

• Comply with company’s policy and procedures on maintenance of personnel hygiene and CER cleanliness to ensure product safety.
• Perform routine and non-routine testing services by using established procedures/protocols (e.g. manufacturing investigations, test method development, method improvement, Lab test investigation, etc.)
• Support testing requirements for both microbiology and chemistry samples.
• Support Environmental monitoring for manufacturing clean room as well as Lab equipment.
• Responsible for reading plates, recording the test results, and verifying test results meet the specification per standard operating procedure.
• Review, follow and perform job functions in compliance with established work instructions and adherence with SOPs, including recording traceable information on device history records.
• Prepare data summaries, reports, and protocols as well as review and approve basic laboratory data and may propose recommendation based on data trending.
• Perform investigations for QA Lab related NCR and/or OOS.
• Lead laboratory investigations and propose recommendations and solutions for manager approval.
• Support validation plans for laboratory equipment and methods
• Coordinate laboratory equipment Calibration and PM requirements to the responsible personnel/ team.
• Responsible for sending samples to the contract lab and any sample preparation if required.
• Perform sample collections as needed.
• Maintains lab supply inventory.
• Responsible for general lab equipment maintenance and overall cleanliness of lab.
• Perform additional duties as assigned by the laboratory manager.