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Ann Mclellan

Independent Consultant, Quality Assurance at Self-employed
Intro Book
Seasoned quality assurance professional with 27 years of experience in the pharmaceutical industry.
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Location
Danbury, Connecticut, United States, US
Skills
  • Gmp
  • Pharmaceutical Industry
  • Computer System Validation
  • Computer Software Testing
  • Fda Gmp
  • Show all
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Bio

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Ann Mclellan is a seasoned quality assurance professional with 27 years of experience in the pharmaceutical industry, including senior roles at Boehringer Ingelheim Pharmaceuticals, Inc. and Pfizer, Inc. She has expertise in GMP, EU GMP, GLP Regulation, Clinical Supplies, and Quality Auditing. Currently, she provides Quality Assurance oversight per GCP for a clinical study sponsored by Edmond Enterprises, LLC.

Experience

  • Self-employed
    • Independent Consultant, Quality Assurance
      • Jan 2012 - Present

      Currently provide Quality Assurance oversight per GCP for a clinical study sponsored by Edmond Enterprises, LLC. The study is approved by the New England Institutional Review Board.

  • HistoRx, Inc.
    • Branford, CT
    • Senior Research Associate
      • Mar 2009 - Dec 2012
      • Branford, CT

      Software validation:Test coordinationAuthored system requirements report, test scripts, test plan, test matrix, summary reportTicket verificationOther QA functions:GLP Archivist and document managementInternal and Vendor auditing

  • Boehringer Ingelheim Pharmaceuticals, Inc.
    • Germany
    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • Senior Compliance Analyst, Quality Assurance
      • 1999 - 2008

      Introduced EU GMP Quality SystemsClinical Supplies Release Officer delegateProcess redesign (release, CAPA, batch review)Lean Six Sigma participationNational/international seminar presenterCorporate Auditor 2004-2011

    • Quality Assurance Auditor
      • 1988 - 1999

      Managed Internal GMP Audit programAudited/evaluated contract manufacturers/laboratoriesDirected FDA pre-Approval inspection activitiesFrequent FDA Escort for inspectionsGLP in-life and report auditingInitiated IND Research Report Auditing program

    • Analytical Sciences Documentation Scientist
      • 1981 - 1988

      Managed and developed documentation and information systems to facilitate the efficiency of the Analytical Sciences Department.

  • Pfizer, Inc.
    • Groton, CT
    • Research Assistant - Analytical Chemistry/Virology
      • 1970 - 1981
      • Groton, CT

      Scientific testing and analysesMethod developmentManaging projectsTraining new techniciansSummarizing data for FDA filing

Education

  • 1977 - 1980
    University of Connecticut School of Masters of Health and Business, Hartford
    MBA, Business Environment and Administrative Policy
  • 1966 - 1970
    University of Maine
    BA, Zoology

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Industry Focus. “Pharmaceuticals and Healthcare”

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