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Director, Quality Assurance

Company: Contract Pharmacal Corp
Location: Hauppauge
Posted on: November 25, 2022

Job Description:

Director; Quality AssuranceHauppauge, NY
About CPC:CPC management demonstrates strong ethics while promoting a culture that provides a sense of safety to our team. We empower our colleagues to self-organize, while encouraging a sense of connection and belonging. Management is open to new ideas, promotes organizational learning and nurtures personal growth from within. Recognized by Long Island Press and Dan's Papers as a "TOP Long Island Workplace", Contract Pharmacal Corp (CPC) is looking for new team members eager to build upon their current skill set. At CPC you are joining an extended family of 1,500 of the industry's top professionals to bring best in class products to market. With over 5,500 dietary supplements, over-the-counter drugs and Rx pharmaceuticals already developed, CPC offers a dynamic and exciting work environment.
Position Summary:The Director of Quality Assurance is responsible for all activities related to cGMP audits and for conducting GMP Manufacturing, Packaging, Testing and Storage investigations.
Responsibilities: Responsibilities include, but are not limited to:

  • Plan and perform internal & external audits (raw material, printed and non-printed components, contract labs/manufacturers) against GMP regulations, or other appropriate regulations as standards
  • Schedule, host and respond to regulatory, customer, and certification audits
  • Oversee the Foreign Supplier Verification Program
  • Manage the document control team - master and production batch record retention, release bulk and finished product to market
  • Oversee the following programs - pest control, environmental monitoring, metrology, change control, investigations, GMP and SOP training, CAPA, Quality Review Board, Material Review Board, product returns, withdrawals and recalls
  • Lead investigation, root cause analysis, and escalation of quality issues to ensure timely and effective issue resolution
  • Perform analysis of reports and production data to identify trends and recommend updates or changes to quality standards, lot disposition, and procedures when necessary
  • Ensure compliance with all relevant quality policies, regulations, and procedures
  • Prepare and/or approve customer, contractor and supplier Quality Agreements
  • Prepare and/or approve Annual Product Reviews
  • Other responsibilities as assigned by executive management
    Education and Experience:
    • Bachelor's degree in a scientific discipline, compliance, or related required
    • Master's degree preferred
    • 10+ years of GMP managerial experience within pharmaceutical quality assurance and compliance; minimum 3 years' experience as a lead auditor Skills, Abilities and Knowledge:
      • US FDA and EU EMEA cGMPs for pharmaceutical and supplement manufacturing
      • Pharmaceutical Quality Systems
      • ICH, USP, and EP Guidances
      • Analytical principles and manufacturing processes
      • Knowledge of computer program validation principles
      • Data analysis
      • Ability to travel, as necessary and appropriate, to company, vendor and other locations to lead and manage staff and personally participate in various job-related activities
      • Decisive action-oriented leader, creative and resourceful problem solver, fair and consistent manager
      • Self-motivated, detail-oriented and comfortable in a fast-paced company environment with minimal direction and able to adjust workload and multi-task productively based upon changing priorities.
      • Solid experience managing concurrent programs, and apply expertise to making concrete decisions that impact the Risk organization and the firm
      • Effective written and oral communication skills to all employee levels
      • Excellent technical writing skills and attention to detail
      • Ability to manage multiple tasks and meet deadlines
      • Proficient in Microsoft Word, Excel, Power Point, Microsoft Office Outlook
      • Required training in SOP, cGMP, and General Safety procedures
        Physical Demands:
        • Required to use hands to operate computer controls.
        • Specific vision abilities required include close vision, ability to focus. Work Environment:
          • Required to be present in the office to collaborate with directors, peers and other departments daily.
          • Responsible for adherence to safety policies.
          • Flexible schedule to meet business requirements.

Keywords: Contract Pharmacal Corp, Stamford , Director, Quality Assurance, Executive , Hauppauge, Connecticut

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