Experience

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  Covidien

  Jan 1976 - Jan 1995

  Managed Quality Assurance Test and Evaluation Lab for physical testing of medical devices and raw materials. Directed team of auditors and technicians responsible for product inspection, internal auditing, testing of raw materials and final release of syringes, needles, and other sterile medical devices. Product testing and competitive analysis. Led field investigations and reported trend analysis for product field failures. Developed test protocols for product investigations, material/product stability testing. Investigated and responded to customer complaints. Responsible for developing and reporting corporate metrics and tracking/trending of product complaints. Managed testing of new and existing products and process changes.

  • Quality Assurance Test & Evaluation Lab Manager

    Jan 1986 - Jan 1995

  • Corporate Product Assurance Engineer

    Jan 1976 - Jan 1986
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  Cpi

  Jan 1995 - Jan 1997

  Director of quality

  Managed Quality Assurance function for injection molding and assembly operation which included medical devices. Created SOPs and developed training curriculum. Performed internal audits and hosted customer and compliance audits. Responsible for investigations, complaint handling and response function. CAPA, Validation, training, and documentation control.

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  Bespak inc.

  Jan 1998 - Jan 2003

  Sr. quality engineer commercial and clinical trial production

  Quality engineer for the manufacture and development of medical devices primarily for inhalation delivery systems and injectables. Managed internal and supplier audits, Performed CAPAs, complaint investigations, batch record review and release. Created SOPs and developed training curriculums.Performed internal audits and component supplier audits. Hosted customer audits and developed audit responses.

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  Pfizer (legacy wyeth)

  Jan 2003 - Jan 2010

  Compliance & training / quality assurance supplier management

  QA Supplier Management, Key role in global supplier management team for the successful implementation of the electronic data base for all GMP suppliers of materials and services. Performed supplier qualifications, assessments, audit reviews, risk assessments, and CAPAs for GMP material suppliers and providers of GMP services.

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  Aj brehm consulting inc.

  Dec 2010 - Jun 2024

  GMP SME Compliance Consultant experienced in strategic planning and execution of project plans and protocols (including Supplier Quality, Validation, Training, auditing, Consent Decree and other regulatory remediation activities Primary areas include Project Management activities associated with GMP Remediation, Supplier and Materials Quality Management, Compliance and Supplier Auditing, for Biotechnology, Pharmaceutical, and Medical Device industries. Performing assessments, Gap analysis, change control activities, creation and editing of SOPs, assessing Change notification and other GMP Compliance related documentation. Show less

  • GMP Compliance/ supplier Quality

    Jun 2011 - Jun 2024

  • Senior Compliance Consultant Supplier Quality

    Dec 2010 - Feb 2024
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  Aj brehm consulting

  Jan 2024 - May 2024

  Contract consultant

  Available for GMP Compliance and Supplier Quality Management contract positions.