Quality Control Analytical Associate II (Flow Cytometry) Allendale, NJ ref

Skills: Flow cytometry (FCM), Medical Technologist, QC experience in a clinical laboratory

Experience level: Associate Experience required: 4 Years Education level: Bachelor’s degree Job function: Quality Control Industry: Biotechnology Compensation: View salary Total position: 2 Relocation assistance: No Visa : Only US citizens and Greencard holders
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
Qualifications include:

BS or BA in Science
Medical Technologist license (preferred)
4 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.
Company Overview:

Our mission is to provide our clients with high quality, scalable, innovative, reliable, and cost-efficient manufacturing platforms and services to advance commercialization of cellular therapies. We are in the business of developing innovative service products for cell therapy manufacture; selling these to senior leaders in charge of development programs in collaboration with their subject matter experts; and delivering these service products for the development and execution of cell-based therapy manufacturing directly to clinical and commercial development teams around the world.