Senior Technician, Laboratory Quality Assurance
JENAVALVE TECHNOLOGY INC•Irvine, CA
•$75,000 - $75,000•Onsite
About The Position
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.
Requirements
- B.S in biological science discipline or equivalent with 5 plus years in experience
- 4+ year experience in medical device/ pharmaceutical/ nutraceutical microbiology or sterilization and laboratory testing.
- Excellent written and verbal communication, interpersonal, and relationship building skills
- Strong cGMP skills.
- Ability to write technical documents
- Demonstrate good documentation practices.
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.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
