Quality Assurance/Control/Regulatory Affairs/Medical Device Complaints
Resume:
P. Amanda Whitaker
Columbus, Ohio 43235
Email: ************@*****.***
Education: The Ohio State University: Bachelor of Science in Wildlife Management, 2004
Experience:
Complaint Specialist and Intake Coordinator, Maetrics Staffing for Depuy Synthes Complaint
Handling Unit, Jan 2013 - June 2013
● Answered incoming complaint calls from primary customers, sales consultants, and healthcare
professionals,
● Documented all information in Catsweb database according to company procedures and FDA CFR Title
21, Chapter 1, subchapter C, part 211, current Good Manufacturing Practices and subchapter H, part
820.198 Complaint Files.
● Interacted professionally and efficiently with internal departments to process customer orders and needs
within company and FDA regulations.
● Assisted in the resolution of quality concerns associated with each complaint while working closely with
MDR specialists, engineering, recall department, and service and repair department.
● Reviewed complaint files, performing complaint closure customer communications as needed, closing
complaint files when possible.
● Maintained a high degree of accuracy, analytical thinking, and adaptability while interfacing with multiple
database applications to acquire additional information pertaining to complaints under review.
● Trained with the use of regulatory reporting decision trees, possessing a firm understanding of the
reporting requirements for U.S. medical device complaints, including MDR reports.
● Highly experienced with MS Word, Excel, Outlook, and multiple databases.
Quality Assurance Coordinator II, Abbott Nutrition, July 2012 – Nov 2012:
● Documented all information in Abbott’s complaint handling system database according to company
procedures and FDA CFR Title 21, Chapter 1, subchapter C, part 211, current Good Manufacturing
Practices and subchapter H, part 820.198 Complaint Files.
● Utilized Abbott’s complaint handling system database to actively review medical device complaints, and
properly document Result Summaries of reviewed data into system as outlined by Abbott Nutrition
guidelines.
● Communicated notice electronically, to internal parties, of MedWatch 3500A submission for internationally
marketed Abbott devices.
● Maintained a high degree of accuracy, analytical thinking, and adaptability while interfacing with multiple
database applications to acquire additional information pertaining to complaints under review.
● Interacted directly with international affiliates via Abbott’s complaint handling system database to perform
complaint closure communications, while performing final review activities, to advance complaints through
the system to complete.
● Trained with the use of regulatory reporting decision trees, possessing a firm understanding of the
reporting requirements for medical device complaints, including MDR reports.
● Demonstrated knowledge of applicable regulatory standards and requirements for documentation
surrounding infant formula pumps, nutritional products, and medical devices.
● Assisted in the resolution of quality concerns associated with each complaint while working closely with
both the Medical and Regulatory Affairs, and Quality Assurance departments.
● Highly experienced with MS Word, Excel, Outlook, Lotus Notes and multiple databases.
Research Assistant, Nationwide Children’s Hospital Research Institute, April 2010 - July 2012:
● Generated cGMP forms following regulatory documentation standards, generated and performed peer
review of SOPs, revised standing SOPs.
● Performed regulatory document review including; clinical labeling plans, clinical dosing plans, aseptic fill
plans, Master Batch Records for gene therapy cGMP lab production, daily cleaning documentation,
quality records, test records, training records, validation plans, and routine maintenance plans.
● Performed processes for the production of various phase 1 clinical trial gene therapy drugs following
MBRs and FDA Regulations.
● Generated technical writing including; standard operating procedures, batch record statements,
equipment validation processes, system performance reports, and system deviation reports.
● Extensive experience training teammates in cGMP and regulatory documentation practices.
● Completed major validation process of cGMP autoclave, and supporting systems, involving the
completion of risk assessment, installation qualification, operational qualification, and functional test
plans, which lead to use of fewer biological indicators, higher overall autoclave process efficiency, and
less cost.
● Passed media fill qualification and performed aseptic fill for various drug lots.
● Performed accurate aseptic cell culture in biosafety cabinets.
● Performed equipment maintenance, scheduled contract maintenance, performed documentation tracking,
and updated equipment log books and databases (Access).
● Participated in ongoing process development, including multiple process improvements, and writing
process development reports.
Quality Assurance Technician, American Health Packaging, Feb 2009 - March 2010:
● Increased profit 41.5% above quarterly goal by developing a rotating production shift.
● Complied with GMP/GLP documentation standards.
● Performed quality control checks according to SOPs on drug packaging.
● Finalized batch records for auditor approval and product release.
● Supported production staff by providing additional materials, paperwork, and personnel.
● Issued packaging components, batch records, and product labels: all based on Master Batch Record
comparisons.
● Maintained quality drug packaging by advising production staff on special packaging directions.
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