QC Analytical Associate III – Allendale, NJ

Our 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 populations
• Performs maintenance, monitoring, and troubleshooting of pertinent equipment
• Performs and assists in the training of other Quality Control Analytical Associates
• Maintains training records and coordinates records retention with Document Control and Training groups
• Tests, documents, and reports results for products or materials following company and/or client procedures following CGMP and/or GTP guidelines
• Performs state proficiency testing and/or client proficiency testing under direct supervision as applicable
• Participates in managing QC materials and supplies
• Performs and assists in equipment and method qualification/validation activities as needed
• Performs reagent and media preparation
• Provides input based on level of knowledge and experience with troubleshooting malfunctioning equipment
• Leads investigations for out-of-specification, out-of-trend, aberrant, and/or non-conforming test results
• Determines root causes and implements intelligent corrective and preventive actions (CAPAs) and monitors CAPA effectiveness
• Initiates, investigates, and prepares deviation reports with input from assigned supervisor
• Brainstorms and implements corrective and preventive actions, as and when applicable
• Documents training and execution of shipping test samples to contract laboratories for testing
• Completes 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 CAPA
• Initiates, assesses, approves, tracks, and trends deviations, Change Controls and CAPAs
• Communicates effectively with other co-workers, departments, management and clients
• Eventually serves as a lead and/or co-lead for client projects
• Manages and drives resolution of quality issues with clients, collaborators, and internal personnel
• Makes 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 system
• Applies expertise of compliance requirements and therefore maintains an inspection-ready state laboratory
• Participates as subject matter expert during audits/inspections
• Works with internal departments and outside vendors, collaborators, and partners effectively for meeting projects timelines and commitments
• Additional tasks as assigned

Qualifications and Competencies:

• BA/BS in a science or relevant field required, although MS is preferred
• Prior cGMP experience required
• GMP, cell count, flow cytometry, documentations, flexibility, CBC, endotoxin, ELISA, qPCR, quality records (DRs, CAPA, CC, doc revision) fluency, multitasking, agility
• Prior QC Lab, clinical lab, microbiology, hematology, blood banking, or immunology experience in a cGMP/GTP environment is a must
• Prior academic and/or industrial cell therapeutic experience is preferred
• Minimum 4-6 years of experience in QC Lab setting or within the biopharma industry