Technician, Quality Control

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.
• 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:
  • Comply with company’s policy and procedures on maintenance of personnel hygiene and CEA cleanliness to ensure product safety.
  • 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.
  • Responsible for reading plates, recording the test results, and verifying test results meet the specification per standard operating procedure.
  • Responsible for sending samples to the contract lab and any sample preparation if required.
  • Perform sample collections as needed.
  • Assist with investigation for out of specification, above alert, action level results and clean room excursions.
  • Maintains lab supply inventory
  • Responsible for general lab equipment maintenance and overall cleanliness of lab.
  • Perform additional duties as assigned by the laboratory manager.
• QC inspector role
  • Conduct routine testing on THV, to include functional, visual, and final inspection processes, along with supporting sterilization preparation.
  • Perform Microbiological monitoring on ViVitro (Leeds) or BDC (Irvine) when required.
  • Conduct Preventative Maintenance and calibration of the ViVitro (Leeds) or BDC (Irvine) equipment.
  • 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.
  • Adhere to Quality System and record retention requirements.
  • Comply with all site Health & Safety requirements.
  • Contribute to continuous improvement efforts related to valve manufacture and inspection processes.
  • Inspect final packaging labels and confirm they are applied correctly per the relevant standards and Work Instructions.
  • Support other areas of the business as necessary and applicable to the role.