Technician, Quality Control

Job DetailsJob Location: Irvine, CA 92618Position Type: Full TimeEducation Level: 4 Year DegreeSalary Range: $25.00 - $33.00 HourlyJob Category: QA - Quality ControlJob 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. QualificationsRequired Education and Experience: Bachelor’s degree in a division of Biology, Chemistry or a Biomedical related discipline 2+ year experience in medical device/ pharmaceutical/ nutraceutical microbiology or sterilization and laboratory testing. 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. Strong cGMP skills. Demonstrate good documentation practices. Knowledge of good laboratory practices and laboratory safety.