Joulé
QC Analytical Associate II
Joulé, Mahwah, New Jersey, us, 07430
Title: QC Analytical Associate II
Before applying for this role, please read the following information about this opportunity found below.Location: Mahwah, NJ areaSchedule: Tuesday to Saturday ( 2:30 pm to 11 pm)Type: Contract to Hire
Responsibilities:The Quality Control Analytical Associate II serves as a support role to clinical and commercial production. The QC Analytical Associate II 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 II 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 equipmentPerforms and assists in the training of other Quality Control techniciansMaintains training records and coordinates records retention with Document Control and Training groupsTests, 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 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 clientsEventually serves as a lead and/or co-lead for client projectsAdditional tasks as assigned
Requirements: BA/BS in a science or relevant field requiredMinimum 2-5 years of experience in Quality Control laboratory setting or within the biopharmaceutical industryPrior cGMP experience requiredGMP, Cell count, flow cytometry , documentation, flexibility, CBC, Endotoxin, ELISA, qPCRPrior QC laboratory, clinical laboratory, microbiology, hematology, blood banking, or immunology experience in a CGMP/GTP environment preferredPrior industrial experience in cell count methodologies preferredPrior academic and/or industrial cell therapeutic experience preferredProficient with computer software such as Microsoft OfficeVisio
Strong written and oral communication skillsStrong presentational skills preferred
Benefits
System 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.
Before applying for this role, please read the following information about this opportunity found below.Location: Mahwah, NJ areaSchedule: Tuesday to Saturday ( 2:30 pm to 11 pm)Type: Contract to Hire
Responsibilities:The Quality Control Analytical Associate II serves as a support role to clinical and commercial production. The QC Analytical Associate II 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 II 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 equipmentPerforms and assists in the training of other Quality Control techniciansMaintains training records and coordinates records retention with Document Control and Training groupsTests, 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 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 clientsEventually serves as a lead and/or co-lead for client projectsAdditional tasks as assigned
Requirements: BA/BS in a science or relevant field requiredMinimum 2-5 years of experience in Quality Control laboratory setting or within the biopharmaceutical industryPrior cGMP experience requiredGMP, Cell count, flow cytometry , documentation, flexibility, CBC, Endotoxin, ELISA, qPCRPrior QC laboratory, clinical laboratory, microbiology, hematology, blood banking, or immunology experience in a CGMP/GTP environment preferredPrior industrial experience in cell count methodologies preferredPrior academic and/or industrial cell therapeutic experience preferredProficient with computer software such as Microsoft OfficeVisio
Strong written and oral communication skillsStrong presentational skills preferred
Benefits
System 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.