Job Title: Quality Control Specialist

As a Quality Control Specialist, you will play a crucial role in testing and developing methods for flow cytometry and QC analysis. You will ensure compliance with regulatory agency requirements by fostering a quality culture within the department and overseeing daily operations to meet client demands. This position offers an opportunity for growth into leadership roles and involvement in project management within a fast-growing company in the cell therapy manufacturing industry.

• Perform testing to help develop methods for flow cytometry and QC analysis.
• Ensure compliance with regulatory agency requirements by enforcing a quality culture throughout the department.
• Schedule and monitor daily operations based on projected client demands.
• Conduct routine walkthroughs of the facility to ensure compliance with regulatory and quality practices.
• Approve investigations and document non-conforming events and out-of-specification results.
• Recommend process improvements for greater efficiency within the department and between sites.
• Participate in department and cross-functional meetings.
• Maintain audit readiness by ensuring staff training, reviewing documentation, and maintaining laboratory cleanliness.
• Interact with internal and external customers to ensure proper sampling, reporting, and resolution of questions and concerns.
• Manage projects and lead initiatives, organizing resources and ensuring collaboration and achievement of goals.
• Build and manage a multi-sector workforce, ensuring recruitment and selection are based on merit principles.
• Train and develop staff, providing performance feedback, appraisals, and addressing conduct issues.
• Promote continuous improvement and innovation, identifying and implementing improvements to increase efficiency.
• Act decisively with good judgment, making informed and timely decisions.
• Build and maintain strong relationships with internal and external stakeholders.
• Communicate effectively, preparing clear and concise written documents and oral presentations.

• Experience in flow cytometry, cell culture, aseptic techniques, and assay development.
• Proficiency in document control and quality control processes.
• 5-7 years of experience in GMP and supervisory roles.
• Bachelor's or Master's degree in a related scientific field.
• Strong knowledge of FDA and EU regulatory standards, with cGMP experience.
• Proficient with computer software, including MS Office and LIMS.

• Experience with microbiology test methods and equipment.
• Experience in training and leading others in a laboratory setting.
• Strong knowledge of analytical test methods and quality systems.
• Excellent collaborative and influencing skills.

This role operates within a professional office environment of a manufacturing operations plant, with exposure to infectious diseases transmittable through human specimens, gases like nitrogen, and corrosive chemicals. The position involves working in an aseptic quality environment, requiring compliance with personal hygiene standards and successful completion of sterile gowning training. The work schedule includes a morning shift from 7:00 AM to 3:30 PM and a second shift from 2:30 PM to 11:00 PM. The environment includes open space seating, cubicles, and office spaces with a moderate noise level.

This is a Contract to Hire position based out of Allendale, New Jersey.