quality assurance specialist resume example with 20+ years of experience

Jessica Claire
Montgomery Street, San Francisco, CA 94105 609 Johnson Ave., 49204, Tulsa, OK
Home: (555) 432-1000 - Cell: - - -
Professional Overview

Well-qualified QA Specialist with a broad background in regulatory compliance, manufacturing, and research and development

Core Qualifications
  • FDA/EPA/OECD/ISO regulations
  • GMP, GLP, ISO monitoring, auditing, reporting
  • In-process audits for compliance to regulations, protocols and SOPs
  • Vendor Audits
  • GMP, GLP Training (new hire and site wide)
  • Manufacturing QA support including Batch Record review
  • Manufacturing process development, validation and transfer to CMO
  • Chemistry and Microbiology analysis
  • Aseptic Manufacturing
  • Cleanroom Technology
  • Environmental Monitoring
  • Equipment Validation
  • Medical Device Qualification
  • Manufacturing Equipment (lyophilizers, sterilizers, filling machines, filters, etc)
  • Multi-disciplinary groups
  • Presentations
  • SOP writing/review
  • Non-conformity report review (OOS, CAPA, OOT, Deviations, etc)

Recruited and trained up an Internal Audit team

Mentored less experienced QA members as to the skills needed

Improved GLP compliance

Developed and presented well-received training in regulations, Quality Systems

Expected in 2011
: Practical Nursing
Bay Path Regional Vocational HS - Charlton, MA

Certificate, 3.5 GPA, voted Class Representative

Expected in
Merrimack College - North Andover, MA

Three years towards BA, Biology major

10/2011 to Current
Quality Assurance Specialist Webstaurantstore Albany, GA,

Provide QA support to Manufacturing and Laboratories (Micro and Chemistry), maintain and monitor Quality Systems, train employees in Regulations and Quality Systems. This support involves: Batch Record review, release of manufacturing suite and materials; review of test results and non-conformity reports, SOPs: review/approval of validation/ GLP protocols and reports; inspections and audits.

08/2011 to Current
Heath Educator Allina Health Systems Edina, MN,

Provide screenings (bone density, diabetes, hypertension,etc) for the community. Educate on disease prevention and management. Market hospital's services. (This is a per diem, weekend seasonal position.)

03/2009 to Current
Transport Aide Catalent Pharma Solutions, Inc. Gaithersburg, MD,

Safely transport patients for procedures, admissions to units, or discharge. Represent hospital as a caring, patient-focused facility, providing excellent customer care to diverse population. (This is a per diem occasional weekend position.

07/2000 to 01/2009
Senior QA Representative Natural Resources Defense Council Washington, DC,

Within a Contract Research Organization, monitored GMP studies and GLP studies for compliance to regulations, protocols and SOPs to ensure data integrity; developed and presented regulatory training; audited study data and reports; prepared written reports of findings; maintained Master Schedule; performed internal audits and vendor audits. Interfaced with clients during audits to address issues.

04/1981 to 07/2000
Staff Scientist DuPont Pharmaceuticals City, STATE,

Within a major pharmaceutical company's Diagnostic Imaging Division, held positions within Manufacturing, QC (Microbiology and Chemistry), and R&D (Pilot Plant, Aseptic Manufacturing). Extensive knowledge of manufacturing equipment and processess, laboratory analysis and equipment. GMP documentation. Performed studies to develop, validate and support manufacturing process; validated equipment and utilities as part of a facility upgrade; produced material for toxicology studies and clinical studies, generating and reviewing batch records.


Annual Regulatory Training Presentations

"Initial On Board" GLP Training, Charles River Labs

"Focusing on GLPs", CRL

"Quality Matters: Bringing the Message Home", CRL

"History of the GXPs: Tragedy to Response", NERCSQA

Memberships/Scholarly Societies

NERCSQA (New England Regional Chapter of Society of Quality Assurance

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Resume Overview

School Attended

  • Bay Path Regional Vocational HS
  • Merrimack College

Job Titles Held:

  • Quality Assurance Specialist
  • Heath Educator
  • Transport Aide
  • Senior QA Representative
  • Staff Scientist


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