Angela Funderburk
Compliance Auditor @Grifols
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WORK HISTORY
Compliance Auditor @Grifols
Durham, NC, US
Coordinates and conducts comprehensive internal cGMP compliance audits at plasma and blood donation centers. This involves a thorough assessment, including donor record reviews, observations of employee performance, evaluation of facility maintenance and cleanliness, and a detailed review of center documentation since the last internal compliance audit, typically conducted every 12 months- Reviews various critical documents, including those related to equipment quality control, calibration, and evaluation, center master files, plasma and biohazardous waste shipping records, employee training, licensure, and certification, deviation management, trend analysis, and management of donors who experience adverse events and who have unsuitable test results- Coordinates and conducts audits of supply and medical device vendors, which encompasses assessment of various aspects such as warehouse management systems, document and change control processes, production and process controls, medical device reporting and tracking, validation procedures, FDA 510K submission documentation, and employee training- Prepares comprehensive reports detailing audit findings, which are then provided to the respective centers. Reviews audit responses and assesses the appropriateness of corrective actions- Verifies effectiveness of Corrective and Preventive Actions (CAPAs) during subsequent audits- Actively participates in continuous improvement projects as required, contributing to ongoing enhancements in compliance and operational efficiency.
EDUCATION
Averett University
Master of Business Administration (MBA), Business Administration and Management, General
Virginia Tech
Bachelor of Science (BS), Psychology
ABOUT ANGELA FUNDERBURK
Compliance Auditor with over 15 years of pharmaceutical experience working in the plasma-derived therapeutics industry. Multiple experiences gained with the overall goal of ensuring donor and employee safety, donor suitability and plasma product quality. Experiences span most aspects of donor center level processes including management of the donor center training program, supervision of daily production activities, managing the center quality program and managing overall center operations. Most recent experiences in SOP technical writing and internal compliance auditing of plasma donation centers and suppliers.
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