QC Analytical Associate I
: Job Details :

Title: Quality Control Analytical Associate ILocation: Mahwah, NJ areaSchedule: 2nd Shift Sunday- Thursday (2:30 pm to 11 pm)Type: Contract to HireResponsibilities:The Quality Control Analytical Associate serves as a support role to clinical and commercial production. The QC Analytical Associate will assist with process check point, stability, and release analytical testing to ensure that quality standards are upheld for all products produced at the facility. Under the direction of the Manager, QC Analytical, responsibilities of the QC Analytical Associate I will include but are not limited to:Performs the accurate execution of all company and/or client test methods and procedures of cellular products to ensure the safety and/or efficacy of different cell populationsPerforms maintenance, monitoring, and troubleshooting of pertinent equipmentTests, documents, and reports results for products or materials following company and/or client procedures following CGMP and/or GTP guidelinesPerforms state proficiency testing and/or client proficiency testing under direct supervision as applicableParticipates in managing QC materials and suppliesPerforms and assists in equipment and method qualification/validation activities as neededPerforms reagent and media preparationProvides input based on level of knowledge and experience with troubleshooting malfunctioning equipmentInvestigates out-of-specification, out-of-trend, aberrant, and/or non-conforming test resultsInitiates, investigates, and prepares deviation reports with input from assigned supervisorBrainstorms and implements corrective and preventive actions, as and when applicableDocuments training and execution of shipping test samples and equipment to contract laboratories for testingCompletes all documentation according to written Standard Operating Procedures in accordance to Current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP).Communicates effectively with other co-workers, departments, management and clients.Additional tasks as assigned.Requirements: BA/BS in a science or relevant field requiredPrior cGMP experience preferredPrior academic and/or industrial cell therapeutic experience preferredMinimum 0-2 years of experience in Quality Control laboratory setting or within the biopharmaceutical industryBasic Laboratory Equipment , Cell count, flow cytometry (nice to have) ,CBC, documentationProficient with computer software such as Microsoft OfficeVisioStrong written and oral communication skillsStrong presentational skills preferredBuild Quality into all aspects of your work by maintaining compliance to all quality requirements.Ensure compliance to all FDA and Worldwide Quality & Compliance regulations (As applicable to the job function).Attend all required Quality & Compliance training at the specified interval.BenefitsSystem One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.