Quality Control Coordinator

Job Code:

Q1042

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JOB DESCRIPTION

The incumbent is responsible for planning, scheduling, and organizing QC activities and management of all QC samples and sampling. The individual participates in projects aimed at cost reduction, efficiency improvements, minimization of downtime and quality and safety enhancement. In this role, the individual must be able to identify and communicate improvement opportunities and results.  The incumbent identifies operational needs for projects, ensuring site/divisional linkage is achieved.  The incumbent must be able to identify and address short term, intermediate, and long-term issues, and be able to appropriately resolve conflict and prioritize work as necessary.  This role may have individual contributors and/or hourly support staff reporting to them in the future.

RESPONSIBILITIES

  • Responsible for the following activities:

  1. Accessioning of QC samples

  2. Stability Program

  3. Scheduling QC Testing

  4. Coordination with Manufacturing to receive samples

  5. Outsourced QC Testing

  • Scheduling Raw Material Testing

  • Responsible for assisting Quality Control Manager in the creation of all Quality Control Coordination quality systems and implementation of those systems

  • Participate in Method Transfer activities

  • Responsible for participation in internal audits, client audits and agency inspections of the site which includes the satisfactory execution, follow up, and closure of inspection and audit items to the satisfaction of all parties. 

  • Support internal and external cGMP manufacture and supply of high-quality cell and gene therapy products including oversight of cGMP sample handling, testing, QC release and stability data analyses and method data trending, out of specification investigations, and Certificates of Analysis creation.

  • Maintain current knowledge base of regulations, corporate policies, and industry best practices, trends, and standards to ensure Quality Control functions remain in compliance with applicable company requirements and global regulations.

  • Other duties as assigned by the Quality Control Manager

QUALIFICATIONS

  • Preferred but not required AS/AA/BS/BA or greater in sciences, preferably in chemistry, biochemistry, biotechnology, pharmaceutical sciences, or related technical field.

  • 3+ years related GMP experience in biotechnology, chemistry, biochemistry, microbiology, pharmaceutical, manufacturing or laboratory environment.