David Flemming has over 25 years of experience in quality assurance and regulatory compliance roles in the pharmaceutical and food industries. He has a proven track record of establishing and improving quality systems, authoring documentation like SOPs, and conducting investigations and root cause analyses. Currently, he is seeking a quality assurance position where he can lead quality programs and ensure compliance with regulations like SQF, HACCP, FDA and ISO standards through documentation management, auditing, and staff training.

1. David Flemming
7 Myers Way mobile 518.429.5674 or Tel. 518.293.5079
Cadyville, New York 12918 E-mail: jhrdflemming@gmail.com
CAREER SUMMARY
Innovative, enthusiastic professional with extensive technical writing experience in the pharmaceutical industry. Proven
track record developing and writing quality system documents to improve regulatory compliance, promote continuous
improvement, and enhance process effectiveness in a fast-paced environment. Professional skills include excellent
written/verbal communication, and problem solving expertise with a strong focus on product integrity including:
 Author Non-Conformance investigations/CAPA  Microsoft Office Suite Word, Excel etc.
 Data analysis and reporting  Hosting regulatory audits (FDA and SQF)
 Staff Training and writing Lesson Plans  Editing documents according to industry standards
PROFESSIONAL EXPERIENCE
Northern Culinary Brands, Plattsburgh, New York
Quality Assurance Manager, (December 2015- Laid Off in September 2016)
 Established, authored, and improved the quality systems in the manufacture of frozen foods
 Interpreted and implemented, Save Quality Foods (SQF), HACCP,and USDA regulatory requirements to assure
final product is made according to national and international standards
 Conducted root cause analysis with cross functional teams to investigate customer complaints, determined,
appropriate Corrective and Preventative Actions (CAPAs),and tracked to completion
 Authored, edited, or approved controlled documents including: Policies, SOPs,and Work Instructions used to
fulfil SQF requirements
CR Bard Inc. Glens Falls, New York
Supplier Quality Engineer, Temporary Contractor (July 2015 to October 2015)
Warning Letter Mitigation
 Reviewed supplier records of components used to manufacture Medical Devices at CR Bard including: supplier
and component qualifications, audit reports, Quality Agreements,and ISO certifications
 Reviewed and confirmed: supplier product failures, CAPAs, evidence of supplier resolution, and subsequent
verification of effectiveness
 Met with the internal Buyers, Engineers, Quality Engineers and Supplier Representative to resolve and close
component failure investigations
Bionique Testing Laboratories, Inc. Saranac Lake,New York
Quality Assurance Manager (July 2009 to November 2014)
Quality Assurance Associate (September 2008 to July 2009)
 Identified laboratory quality events, initiated the investigation, determined the root cause,and authored robust
CAPA plans
 Served as a lead investigator and met with subject matter experts, quality control, quality assurance,management,
and the client/manufacturer representative to compose, edit and/or approve investigations
 Managed/reviewed equipment, process and supplier change controls to ensure a robust process before,during, and
after the modification

2. David Flemming
7 Myers Way mobile 518.429.5674 or Tel. 518.293.5079
Cadyville, New York 12918 E-mail: jhrdflemming@gmail.com
 Reviewed, modified, and approved process validation data and reports to align with strategic goals of the
company
 Coordinated/hosted two successfulFDA inspections and many client audits including: reporting findings to
management, authoring written responses to auditor’s observations, and tracking resulting CAPAs to closure
 Managed the supply program including: qualification of new suppliers, administration of Supplier Quality
Questionnaires, negotiating Quality Agreement Contracts, and conducting supplier on-site audits and writing
audit reports
 Conducted internal process-flow inspections according to SOPs,determined opportunities for development and
formalized a process change as needed
 Evaluated quarterly quality trending data, authored and/or approved associated reports, presented to management,
and determined corrective actions for trends
Stryker Biotech, West Lebanon, New Hampshire
Analyst III (2007 to 2008)
 Conducted physical and chemical release testing of a pharmaceutical product
 Edited SOPs and forms to improve functionality and accuracy
 Utilized, maintained, and calibrated specialized tools and equipment to collect and analyze data
 Created/edited CAPA and appropriate change control documents
Bristol Myers Squibb, Syracuse,New York - Aerotek (consultant)
Analyst I (2006 to 2007)
 Conducted release testing of the protein product and reported results
 Edited and created SOPs and technology transfer documents
 Utilized, maintained, and calibrated specialized tools and equipment to collect and analyze data
Wyeth Research, Chazy and Rouses Point, New York
Supervisor II, Microbiology (2004 to 2005)
Research Scientist II (2000 to 2004)
Scientist I, Experimental Pathology/Genetic Toxicology (1995 to 2000)
Staff Toxicologist, Reproductive Toxicology (1992 to 1995)
 Authored/edited laboratory and manufacturing investigation reports using Trackwise Quality Management System
 Performed review of study files and General Technical Reports for accuracy and compliance
 Utilized and maintained specialized equipment to collect and analyze data
 Planned, designed, and equipped a state-of-the-art quality control suite to conduct scientific studies
EDUCATION
State University of New York, Plattsburgh, NY
M.A., Biology (with a focus on cell and molecular biology)
B.S. Biology and Biotechnology
PROFESSIONAL TRAINING/CERTIFICATION
Conducting Bullet Proof CAPA Investigations
Hazard Analysis Critical Control Point (HACCP) Certified