The individual must have proven knowledge of Quality Control System development including creation of SOPs, Work Instructions, etc. The individual is recognized as a subject matter expert with regard to Quality Control Analytical practices and procedures and serves as the main point-of-contact for all QC Analytical activities. The incumbent is responsible for planning, scheduling, and organizing QC activities related to meeting the compliance, supply, profit plan and strategy objectives of the company and the department. 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.
• Responsible for all activities related to the Quality Control Analytical group.
• Responsible for assisting Quality Control Manager in the creation of all Quality Control Analytical quality systems and implementation of those systems.
• Participate in Method Transfer activities.
• Collaborate with cross-functional teams to resolve complex method development challenges.
• Direct, develop and evaluate team members to assure all individuals in the Quality Control Analytical group reach their potential.
• 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.
• Participate in method qualification and validation, transfer, and testing.
• 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
• BS/BA or greater in sciences, preferably in chemistry, biochemistry, biotechnology, pharmaceutical sciences, or related technical field.
• 6+ years related GMP experience in biotechnology, chemistry, biochemistry, microbiology, pharmaceutical, manufacturing or laboratory environment.
• Manager of Quality/Organizational Excellence (CMQ/OE) is preferred