QC Analytical Associate II - 236040 at Medix™ in Allendale, New Jersey

Job Description:

• Perform accurate execution of company/client test methods and procedures for cellular products to ensure quality and compliance.
• Conduct cell culture processes and flow cytometry assays to analyze cell populations.
• Maintain, monitor, and troubleshoot laboratory equipment to ensure consistent operation.
• Assist in training and mentoring other Quality Control technicians.
• Maintain and coordinate training records with Document Control and Training groups.
• Test, document, and report results for products or materials following CGMP and/or GTP guidelines.
• Perform state proficiency and/or client proficiency testing under direct supervision as applicable.
• Participate in managing QC materials, supplies, and inventory.
• Assist with equipment and method qualification/validation activities.
• Prepare reagents and media as required.
• Investigate and troubleshoot out-of-specification, out-of-trend, and non-conforming test results.
• Initiate and prepare deviation reports and collaborate with supervisors on corrective/preventive actions.
• Oversee documentation and shipping of test samples to contract laboratories.
• Complete all documentation according to CGMP and Good Documentation Practices (GDP).
• Collaborate effectively with coworkers, departments, management, and clients.
• Act as lead or co-lead for client projects, providing expertise and oversight.
• Take on additional tasks as assigned.

• Bachelor's degree in a scientific or related field (BA/BS) required.
• 2-5 years of experience in a Quality Control laboratory setting or biopharmaceutical industry.
• Hands-on experience with cell culture and flow cytometry is highly preferred.
• Strong knowledge of CGMP, GTP, and related quality standards.
• Effective communication, organizational, and troubleshooting skills.