QC Analytical Associate I – 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 serves as a supporting 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.

Essential Functions and Responsibilities:

• 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 populations
• Performs maintenance, monitoring, and troubleshooting of pertinent equipment
• 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
• Investigates out-of-specification, out-of-trend, aberrant, and/or non-conforming test results
• 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 and equipment 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).
• Communicates effectively with other co-workers, departments, management and clients.
• Additional tasks as assigned.

Qualifications and competencies:

• BA/BS in a science or related field required
• Prior cGMP experience preferred
• Basic lab equipment experience, cell count, flow cytometry, CBC, documentation
• Prior academic and/or industrial cel therapeutic experience preferred
• Minimum 0-2 years of experience in QC Lab setting or withing the biopharma industry
• Candidate must be detail oriented, can multi-task, work in a team environment, and have the flexibility to adapt to company growth as well as its evolving responsibilities