Senior Technician, Laboratory Quality Assurance
Summary
A Senior Laboratory QA Technician performs microbiological and chemistry testing on samples, ensures compliance with SOPs, and investigates quality issues to maintain product safety and manufacturing standards.
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.