Senior Technician, Laboratory Quality Assurance

Jenavalve Technology Inc; Irvine (CA); On-site; USD 70,000 - 90,000; Full time

Job summary

Jenavalve Technology Inc. is seeking a Senior Technician for Laboratory Quality Assurance to support sustaining manufacturing and special projects by performing microbiological and chemistry testing on diverse samples and maintaining documentation.

The role involves ensuring product safety through adherence to SOPs, conducting lab investigations, coordinating equipment maintenance, and contributing to data trending and reporting.

Qualifications

• B.S in biological science or equivalent with 5+ years experience.
• 4+ years in medical device/pharma/nutraceutical microbiology or sterilization and lab testing.
• Strong cGMP skills.
• Excellent written and data documentation practices.

Responsibilities

• Perform routine and non-routine testing services using established procedures.
• Support testing requirements for microbiology and chemistry samples.
• Environmental monitoring for manufacturing clean room and lab equipment.
• Read plates, record and verify results against SOPs.
• Prepare data summaries, reports and protocols; review basic lab data and propose recommendations.
• Lead QA Lab investigations (NCR and/or OOS) and propose solutions for manager approval.
• Coordinate calibration and PM of lab equipment.
• Send samples to contract labs and prepare samples as needed.
• Maintain lab supply inventory and general lab cleanliness.
• Perform additional duties as assigned by the laboratory manager.

Skills

Communication

Written communication

Interpersonal skills

Documentation practices

cGMP

Education

B.S. in biological science

Tools

Lab equipment calibration

Environmental monitoring

Job description

Job Title: Senior Technician, Laboratory Quality AssuranceSupervisor/Manager Title: Manager, LaboratoryJob 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 methodsCoordinate 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.Required Education and Experience:B.S in biological science discipline or equivalent with 5 plus years in experience4+ year experience in medical device/ pharmaceutical/ nutraceutical microbiology or sterilization and laboratory testing.Skills and Abilities Required for This Job:Excellent written and verbal communication, interpersonal, and relationship building skillsStrong cGMP skills.Ability to write technical documentsDemonstrate good documentation practices.