Senior Technician, Laboratory Quality Assurance

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

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.

Qualifications

Required Education and Experience

• 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.

Skills And Abilities Required For This Job

• Excellent written and verbal communication, interpersonal, and relationship building skills
• Strong cGMP skills.
• Ability to write technical documents
• Demonstrate good documentation practices.