Job Title: Technician, Laboratory Quality Control
Supervisor/Manager Title: Senior Manager, Laboratory
Job Description Summary:
- The laboratory technician is responsible to support sustaining manufacturing by performing microbiological and chemistry testing on various kinds of samples and document the results to assure quality.
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Responsible for supporting the Quality department with quality control activities related to the manufacture of the THV within the Leeds and Irvine production facilities. To include in-process and final inspection, labelling/packaging, documentation, and environmental monitoring. The role holder will also provide routine reports and communications to provide timely updates on inspection status.
Job Responsibilities:
- Lab tech role:
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Comply with company’s policy and procedures on maintenance of personnel hygiene and CEA cleanliness to ensure product safety.
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Perform microbiological tests, including in-process solutions/water bioburden tests, environmental monitoring, basic microbial characterization such as gram staining.
- Perform Chemistry testing for solutions, such as pH, concentration, and raw glutaraldehyde test.
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Responsible for reading plates, recording the test results, and verifying test results meet the specification per standard operating procedure.
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Responsible for sending samples to the contract lab and any sample preparation if required.
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Perform sample collections as needed.
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Assist with investigation for out of specification, above alert, action level results and clean room excursions.
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Maintains lab supply inventory
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Responsible for general lab equipment maintenance and overall cleanliness of lab.
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Perform additional duties as assigned by the laboratory manager.
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QC inspector role
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Conduct routine testing on THV, to include functional, visual, and final inspection processes, along with supporting sterilization preparation.
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Perform Microbiological monitoring on ViVitro (Leeds) or BDC (Irvine) when required.
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Conduct Preventative Maintenance and calibration of the ViVitro (Leeds) or BDC (Irvine) equipment.
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Conduct audits on the in-process paperwork associated with the manufacturing process including, but not limited to: manufactured valve DHRs, Jasmine preparation and ancillary logs. Provide support to the Engineering staff by gathering data on clinical product to allow decisions to be made on functionality.
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Adhere to Quality System and record retention requirements.
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Comply with all site Health & Safety requirements.
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Contribute to continuous improvement efforts related to valve manufacture and inspection processes.
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Inspect final packaging labels and confirm they are applied correctly per the relevant standards and Work Instructions.
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Support other areas of the business as necessary and applicable to the role.
Required Education and Experience:
- Bachelor’s degree in a division of Biology, Chemistry or a Biomedical related discipline
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2+ year experience in medical device/ pharmaceutical/ nutraceutical microbiology or sterilization and laboratory testing.
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Must be familiar with 21CFR820 and ISO 13485 requirements. Hands on experience with these requirements is preferred.
Skills and Abilities Required for This Job:
- Good written and verbal communication skills.
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Strong cGMP skills.
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Demonstrate good documentation practices.
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Knowledge of good laboratory practices and laboratory safety.
