Quality Control Laboratory Manager

QC Manager – Fairfield, NJ

Summary :

The QC Manager is primarily responsible for the daily operation of pharmaceutical Quality Control Laboratory. This position will manage the staff to schedule and perform all necessary testing to support manufacturing and release requirements. Responsible for training and personnel development. This is a hands- on position. In addition to managerial responsibilities, this position will be performing analytical testing including wet chemistry, GC, HPLC, etc. as needed

Responsibilities :

• Lead, coach and manage a team of analysts to ensure data integrity and performance to meet business objectives
• Train and develop analysts
• Formulate, document, and maintain quality control standards and on-going quality control objectives
• Schedule workload to meet release objectives and deadlines
• Review, interpret, analyze and report HPLC / GC / UV / FTIR data according to USP / NF / BP / EP / IP / JP / CEP / cGMP, and internal guidelines
• Author analytical methods and SOPs
• Clean, maintain, and troubleshoot HPLC / GC / UV / FTIR instruments
• Develop specifications and analytical methods as required
• Develop analytical methods to support product development projects
• Prepare analytical method validation protocols and reports
• Perform Laboratory Investigations, root cause analysis, CAPA, Change Controls, Validations, Stability Programs, APRs, statistical analysis, environmental monitoring of air, water, and surfaces, as needed.
• Manage the outsourcing process of testing to contract laboratories
• Ensure lab safety and manage chemical inventory
• Improve the compliance of the laboratory operations as well improve the efficiency and reduce the cost of the operations
• Perform duties of QC Analyst as needed including HPLC sample preparation and testing and any other testing requirements
• Audit the work of QC Analysts
• Other duties assigned by Management

Education :

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