Job Description

Job Description

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 :

• Bachelor’s degree in a scientific discipline (Chemistry preferred) with a minimum of 5 years’ experience in laboratory management OR Master’s degree in a scientific discipline (Chemistry preferred) with a minimum of 3 years’ experience in laboratory management

Experience Requirements:

• Experience with Empower 3
• Experience working in an FDA regulated environment
• Experience with GC sample preparation and testing
• Knowledge of USP Monograph testing, analytical method development & validation
• Knowledge of CFR & ICH Regulatory Guidelines
• Knowledge of cGMP processes, lab safety and GDP.

Computer Skills:

• Proficiency in Microsoft Word
• Proficiency in Microsoft excel
• Proficiency in Empower 3

Other requirements:

• Has significant technical knowledge of scientific principles, theories, and practices of analytical chemistry in an FDA inspected pharmaceutical quality control laboratory.
• Able to perform complex mathematical problems
• In depth knowledge of all laboratory equipment, practices, and procedures
• Demonstrated managerial abilities
• Problem analysis, solving and resolution skills
• Has excellent oral and written skills
• Has excellent interpersonal skills
• Is self motivated
• Has a very high attention to detail
• Has a positive attitude
• Must speak, read, and write in English
• Able to lift 25 pounds
• Able to stand for extended periods

Hours :

• Standard: 8:30 AM to 5:00 PM, Monday through Friday
• Occasionally: Extended hours and/or Saturday and Sunday may be required as necessary to support manufacturing.

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