Quality Control Associate

3 days ago

Allendale, United States ClinLab Staffing Full time

QC Analytical Associate II – 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 II serves as a supporting 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.

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

Performs and assists in the training of other Quality Control technicians

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

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 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

Eventually serves as a lead and/or co-lead for client projects

Additional tasks as assigned

Qualifications and Competencies:

BA/BS in a science or relevant field required

Experience in GMP, cell count, flow cytometry, documentations, flexibility, CBC, ELISA, qPCR

Prior QC laboratory, clinical laboratory, microbiology, hematology, blood banking, or immunology experience in a cGMP/GTP environment preferred

Prior industrial experience in cell count methodologies preferred

Prior academic and/or industrial cell therapeutics experience preferred

Minimum 2-4 years of experience in QC lab setting or withing biopharma industry

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