Senior Laboratory QA Technician: Microbiology & Chemistry

JenaValve Technology, Inc.; Irvine (CA); On-site; USD 70,000 - 100,000; Full time

Job summary

JenaValve Technology, Inc. is seeking a Senior Technician in Laboratory Quality Assurance to support sustaining manufacturing and special projects by performing microbiological and chemistry testing and maintaining documentation.

The role requires 5+ years in biology-related labs and strong cGMP knowledge. You will perform routine testing, support environmental monitoring, read plates, document results, and lead investigations for NCRs/OOS with a focus on data trending and SOP adherence within a

Qualifications

• B.S in biological sciences or equivalent with 5+ years experience.
• 4+ years in medical device/pharmaceutical/nutraceutical microbiology or sterilization and laboratory testing.

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.

Skills

Communication skills

cGMP knowledge

Technical writing

Documentation practices

Education

B.S in biological science

5+ years microbiology/lab experience

Job description

JenaValve Technology, Inc. is seeking a Senior Technician in Laboratory Quality Assurance to support sustaining manufacturing and special projects by performing microbiological and chemistry testing and maintaining documentation.

The role requires 5+ years in biology-related labs and strong cGMP knowledge. You will perform routine testing, support environmental monitoring, read plates, document results, and lead investigations for NCRs/OOS with a focus on data trending and SOP adherence within a