Senior Quality Control Analyst

QC Analytical Associate III - Allendale, NJOur vision is creating future cell therapy miracles together. We are a leading global contract development and manufacturing organization dedicated to the advancement of cell and gene therapy products. We believe in the transformative potential of cell and gene therapies, and we are shaping the future of medicine. We open doors in the regenerative medicine industry for those looking to transform medicine while continuously improving an innovative, growing company.The Quality Control Analytical Associate III serves as a support role to clinical and commercial production. The QC Analytical Associate III 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.Essential Functions and Responsibilities:Performs 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 Analytical AssociatesMaintains 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 equipmentLeads investigations for out-of-specification, out-of-trend, aberrant, and/or non-conforming test resultsDetermines root causes and implements intelligent corrective and preventive actions (CAPAs) and monitors CAPA effectivenessInitiates, 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)Ensures timely issuance, review, and approval of Certificate of Analysis, alongside timely closures of batch records, deviations, and CAPAInitiates, assesses, approves, tracks, and trends deviations, Change Controls and CAPAsCommunicates effectively with other co-workers, departments, management and clientsEventually serves as a lead and/or co-lead for client projectsManages and drives resolution of quality issues with clients, collaborators, and internal personnelMakes informed and independent decisions on complex issues in collaboration with key stakeholders and alignment with company policies.Manages completion of document changes and maintains the internal QC change control systemApplies expertise of compliance requirements and therefore maintains an inspection-ready state laboratoryParticipates as subject matter expert during audits/inspectionsWorks with internal departments and outside vendors, collaborators, and partners effectively for meeting projects timelines and commitmentsAdditional tasks as assignedQualifications and Competencies:BA/BS in a science or relevant field required, although MS is preferredPrior cGMP experience requiredGMP, cell count, flow cytometry, documentations, flexibility, CBC, endotoxin, ELISA, qPCR, quality records (DRs, CAPA, CC, doc revision) fluency, multitasking, agilityPrior QC Lab, clinical lab, microbiology, hematology, blood banking, or immunology experience in a cGMP/GTP environment is a mustPrior academic and/or industrial cell therapeutic experience is preferredMinimum 4-6 years of experience in QC Lab setting or within the biopharma industry

Created: 2024-11-07