Quality Assurance Testing
Resume:
DAVID A. BAIN
Kenosha, WI ***42
**********@*****.***
SUMMARY
Energetic and self-motivated Technical Writer/ CAPA with 8 years of Quality Assurance in
pharmaceutical industry. Organized, creative problem solver with strong communication and
multitasking skills. Successfully handle multiple projects. Expertise in improving metrics,
resolving issues, testing packets for Quality Assurance, complying with FDA regulations, and
reporting to auditor and regulatory agents. Implement and maintain effectiveness of quality
systems. CAPA Initiator/Evaluator Certification.
PROFESSIONAL EXPERIENCE
ABBOTT LABORATORIES, Abbott Park, IL 2000-2011
Process Scientist I – ADD (Abbott Diagnostic Division), 2007-2011
• Authored, investigated and gained approval from quality, planning, technical support and
regulatory affairs for site level and divisional nonconformance reports for internal CAPA
board, auditors and FDA.
• Analyzed and reviewed all operating procedures for investigations and data management
• Restricted nonconforming serum or plasma by placing material in controlled containers,
which results in avoiding utilization and prevent failure in quality testing.
• Prepared Exception Report to document results of nonconforming material to denote sub-
quality elements and make recommendations to correct issues to generate quality serum.
• Submitted report to Quality Planning Support to gain approval.
• Prioritized site Quality approvers for Exception Reports and conducted follow-up, which
improved department monthly metrics from 27% to over 95% on-time approvals for CAPA.
• Reduced Exception report backlog and assisted in sustaining a minimum 90% timeless to
reduce costs and increase shipments for high customer satisfaction.
• Completed coursework to gain CAPA certification to gain Quality and application reliability.
• Attended meetings to discuss monthly metrics and department goals, and tracked individual
performance, which improved effectiveness of 13-member team.
Advance Quality Technician- ADD (Abbott Diagnostic Division), 2004-2007
• Wrote CAPA noncompliance Exception Reports to support the testing production for HIV,
and HTLV I /II, which increased production to meet goals prior to deadlines.
• Trained and mentored three new employees to write reports in CAPA to improve the
efficiency for quality testing for compliance with operating procedures.
• Participated in area audits for AQA of laboratories every six-months to achieve compliance
with company regulations and FDA standards.
• Prioritized with area quality for approval of noncompliance Exception Reports
Incoming Quality Technician – ADD (Abbott Diagnostic Division), 2000 – 2004
• Coordinated weekly meetings to improve communications with planning to prioritize testing
and work order packet verification resulting in increased decision making process for the
purchase of new plasma and serum.
• Demonstrated proficiency on all testing equipment to ensure proper use and increased
efficiency for testing all incoming plasma and serum.
• Inspected and verified completed testing paper work to ensure compliance with operating
procedures before final approval.
• Appointed supervisor for radioactive material to ensure compliance with federal and state
laws for the proper use for testing and disposal of radioactive material.
• Trained and mentored 4 new employees on laboratory equipment for testing and general
maintenance to improve functionality and accuracy for quality testing.
• Streamlined the process for corporate record retention operations in quality area to achieve
increased effectiveness by removing outdated retention forms and eliminate duplicates.
UNITED STATES NAVY
Reserve Unit, Fleet Marine Force Corpsman, Milwaukee, WI, 1997-present
Active Duty, Corpsman, 1991-1995
• First Aid and CPR certified.
• Certified in IV therapy, blood draw, immunizations, and administering medication.
• Provide military assistance by injecting proper immunizations and drawing blood samples to
maintain 100% readiness for reserve center.
• Appointed Medical Supervisor and coordinated six direct reports, which streamlined medical
records, maintained new supply inventory, and reviewed expiration dates on medications.
EDUCATION
Bachelor of Science, Biology Major, History and Antrhropology Minors,
University of LaCrosse, WI
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