Quality Control Manager

• Responsible for overseeing and prioritizing product testing in the following areas according to establish procedures and production timelines
• Responsible for providing supervision and direction for the professional supervisory staff in Quality Control department and oversees
• Responsible for managing department budget
• Responsible for the support of product COA release
• Responsible for part 11 compliance throughout the laboratory in addition to support for the automated chromatography and laboratory information system
• Responsible for directing and reviewing all investigations due to out of specification or out of trend data and reporting these occurrences to upper management.
• Responsible for maintaining adequate laboratory supplies to meet operational expectations
• Ensure cGMP compliance with methods, procedures, instruments and employee training
• Maintain a laboratory safety and hazardous material disposal program to ensure support of environmental Health and Safety guidelines
• Review and provide recommendations for improvement to new and current methods and specifications including GTM's and SOP's

• Generally a BSc degree or higher is required. Relevant experience in a scientific discipline closely related to pharmaceutical operations is strongly preferred.
• A minimum of five years of supervisory experience in a Quality Control laboratory environment is required.
  • Possess a specialized knowledge of document systems, analytical methods and instrumentation
  • Requires advance skills in prioritizing workflow
  • Excellent problem solving skills and good communication skills, both oral and written.
  Proficiency in the use of Microsoft Office products as well as other software utilized within the scope of this position.