Manager, Quality Control

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Job description

Manages, plans, coordinates, directs, and evaluates all activities associated with the Chemistry Laboratory. Ensures chemical testing is performed and in compliance with USP, FDA regulations, SOPs, ICH, ISO, and other regulatory requirements. Manage, direct, and mentor QC Chemistry staff.

• Drafts, reviews, updates and approves laboratory quality systems, validations, test methods, specifications, and SOPs.
• Manage Stability program according to FDA regulations, ICH, etc.
• Reviews and approves laboratory logbooks, notebooks, and documentation
• Oversees and/or purchases laboratory equipment and necessary supplies for the laboratory.
• Develop and revise as necessary, a Chemistry organization structure that is efficient and supports the business needs under management guidance.
• Recruit, develop, train, and mentor staff such that they have the education, training, experience, or any combination thereof to perform their job functions. This includes succession planning.
• Ensuring completion of Analytical R&D method transfers into Quality Control laboratory.
• Reviewing QC documents that support analytical requirements in accordance with USP guidelines.
• Generating summary and trend analysis reports.
• Investigate OOS occurrences according to company procedures.
• Responsible for cGMP compliance and continuous quality improvement in the laboratory.