Job Description

Job Description

This Quality Control Manager is responsible for oversight of all quality control testing of raw materials, intermediates and final products. This includes test methodology and documentation required for quality control within government and industrial specifications. The incumbent works closely with quality assurance to ensure that products meet and/or exceed applicable FDA and cGMP standards.

Responsibilities:

• Ensure all work is completed within the boundaries of corporate, governmental and business unit EHS practices and guidelines.
• Manage the resources of the Quality Control functions, cGMP systems to ensure products are consistently manufactured and tested according to the cGMP standards.
• Provides appropriate coaching and performance feedback to all direct reports and assures that all team members are being developed.
• Responsible for the Quality Control Department budget and its control.
• Maintain active customer and governmental contacts concerning technical problems and product compliance and performance.
• Assure all testing procedures are written, validated, and maintained.
• Monitor and direct all quality control activities, which includes but is not limit too, staff scheduling, prioritization of department’s work, product team participation, and determination of projects as needed for continuous improvement.
• Leads quality control investigations and determines root cause to provide effective resolutions, such as CAPA’s.
• Responsible for the overall release/results of materials from the lab.
• Evaluates metrics to develop/implement efficiency improvements.
• May perform all work associated with Quality Control Chemist duties to meet the department needs.

Requirements:

• BS Chemistry or related science
• Minimum of ten (10) years’ direct experience in organic analytical/instrumentation chemistry
• Minimum of seven (7) years direct experience in organic analytical/instrumentation chemistry lab supervision.
• Chromatography experience

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