Experience

• 

  The Olde Mecklenburg Brewery

  • Quality Control and Production Manager

    • Mar 2020 - Present

• 

  Bristol-Myers Squibb

  • United States
  • Pharmaceutical Manufacturing
  • 700 & Above Employee

  • Manager, GMP Compliance

    • May 2016 - Sep 2018

    Ensured alignment of site procedures and processes with company directives/policies and current regulatory filings. Represented the site as a Quality Facilitator for internal audits and regulatory inspections; interacted one-on-one with auditors and inspectors. Supported aggressive regulatory filings and renewals; worked directly with country regulatory managers to provide the required documents. Organized and led monthly Quality Council meetings; engaged senior management participation for Department reporting and accountability. Lead cross functional teams to create and implement new Quality processes for GMP service provider oversight and for an Integrated Facilities Management (IFM) material release. Maintained the site Risk Registry Library, site Master File and the site Quality Plan.

  • Supervisor, Quality Assurance Operations

    • Sep 2008 - May 2016

    Responsible for final review and approval of material releases, material/vendor qualifications, and certificates of analysis and compliance. Participated in conducting self-inspections, supported regulatory filing activities and ensured inspection readiness of release documentation. Restructured the vendor qualification program by organizing a cross-functional team to map and challenge the end-to-end process. Maintained the inventory control process for market filing fragmentation; performed final assessment and authorization of all drug substance shipments, ensuring suitability for each market. Coached team members to further build technical skills, good safety practices and core behaviors; supported personal career development of direct reports to ensure talent retention.

  • Team Lead, Product Disposition, Syracuse Quality Assurance Operations

    • Nov 2006 - Sep 2008

    Lead the quality team responsible for the release of all materials and challenged team performance to exceed target release timelines. Participated in external audits of cell bank contract laboratory testing facilities. Site Subject Matter Expert for cell bank release. Performed periodic assessments of department procedures against corporate policies/directives to ensure compliance.

  • Quality Assurance Analyst, Syracuse Quality Assurance Operations

    • Jun 2003 - Nov 2006

    Reviewed drug substance and cell bank batch record documentation for accuracy and completeness, and assured compliance with procedures and cGMPs. Coordinated and performed contextual review activities to support the release of product and cell bank lots.

  • Quality Control Technologist, Wet Chemistry Department

    • Jul 2000 - Jun 2003

    Performed analytical testing of raw materials, intermediates, stability and water samples.

• 

  Anheuser Busch Inc

  • Baldwinsville, New York

  • Kettle Floor Operator (Weekend Warrior)

    • Jan 2000 - Nov 2000
    • Baldwinsville, New York

    Initiated batching of beer via a computerized switch panel to control and maintain the process.Maintained accurate records throughout the initial batching stages, working directly with maintenance personnel for equipment troubleshooting.Performed scheduled kettle and line CIP.

• 

  Medeva Pharmaceuticals

  • Rochester, New York Area

  • Quality Microbiology Technician

    • Feb 1993 - Jun 1998
    • Rochester, New York Area

    Performed testing of raw materials and OTC finished products in accordance with USP and standard methods. Performed collection and testing environmental monitoring and water samples of all process areas.

• 

  Onondaga County

  • Syracuse, New York Area

  • Laboratory Technician (Chemical, Biological)

    • Jan 1991 - Sep 1992
    • Syracuse, New York Area

    Performed daily testing of samples in accordance with Standard Methods.

• 

  Upstate Laboratories, Inc.

  • Syracuse, New York Area

  • Metals / Wet Chemistry Technician

    • Feb 1990 - Jan 1991
    • Syracuse, New York Area

    Performed laboratory testing; gained basic knowledge of laboratory operations and documentation.