Responsible for performing Quality control activities with minimal supervision of daily tasks in support of HCATS and client procedures. Procedures are expected to be performed with precision and accuracy and demonstrate a high level of documentation accuracy and clarity. Compliant with all applicable SOP’s and good documentation practices as well as cGMP and cGTP requirements. Identify problems that may adversely affect test performance or reporting of test results, correct the problems encountered or immediately notify your manager. Document all corrective actions taken when test systems deviate from the laboratories established performance specifications.
Duties and responsibilities:
- Perform the accurate execution of test methods and procedures.
- Maintain inventory of QC materials and lab supplies, including monitoring and ordering
- Perform maintenance, monitoring, and troubleshooting of pertinent equipment
- Perform reagent and media preparation
- Compliant with all applicable SOPs and good documentation practices(GDP) as well as cGMP/GCTP requirements
- Conduct test, review and release test results for products or materials
- Perform and assist in equipment qualification and method validations as needed Perform state proficiency testing and/or client proficiency testing under direct supervision as applicable
- Investigate Out of Specification (OOS), Out of Trend (OOT) and/or non-conforming test results
- Assist in investigations, and preparation of deviation reports, with input from the manager or lead, in a timely manner and implements corrective actions and preventive actions
- Packaging and shipping samples to contracted Laboratories for testing and/or to Clients
- BS or BA in Science
- Medical Technologist license (preferred)
- 6 years’ QC experience in a clinical laboratory, microbiology, hematology, blood banking, immunology or QC laboratory preferably in a cGMP/cGTP environment.
- Flow Cytometry experience required.
- Must be proficient in QC test methods/procedures and use of the QC lab equipment
- Working knowledge of GxP regulations and standards Working knowledge of quality systems: Change control, Deviations, CAPA, etc.