Quality Assurance Medical Device
Resume:
P. Amanda Whitaker
Columbus, Ohio 43235
Email: ************@*****.***
Education: The Ohio State University: Bachelor of Science in Wildlife Management, 2004
Areas of Expertise:
● Over 5 Years of Laboratory Experience; Detail oriented, self-directed and highly adaptable to new
situations, excellent manual dexterity, extensive experience with different types of Autoclaves.
● Over 4 Years of Experience; cGMP work methods, documentation, Document Review, also cell culture,
microbiology and wet chemistry techniques.
● Technical Writing including; standard operating procedures (SOP), Batch Record Statements, medical
device complaint ticket review summaries, equipment validation processes, system performance reports,
System Deviation Reports.
● Extensive Experience Training Teammates in GMP Areas including; technical cleaning, aseptic gowning,
documentation, and database systems.
● Completed Major Validation Process of cGMP Autoclave, and supporting systems, involving RA, IQ,
OQ, and FTPs, which lead to use of fewer BIs, higher overall Autoclave Process Efficiency, and Less
Cost.
Experience:
Quality Assurance Coordinator II, Abbott Nutrition, July 2012 - Nov 2012:
● Utilized Abbott’s Complaint Handling System to actively review medical device complaints, and properly
document Result Summaries of reviewed data into system as outlined by Abbott Nutrition guidelines.
● Maintained a high degree of accuracy and analytical thinking while interfacing with multiple database
applications to acquire additional information pertaining to complaints under review.
● Reviewed all collected information regarding Abbott international complaints and assured documentation
of each complaint in a manner that is in accordance with FDA regulations.
● Interacted directly with International Affiliates via Abbott’s Complaint Handling System, while
performing final review activities, to advance the complaints through the system to complete.
● Assured the resolution of all quality concerns associated with each complaint ticket while working closely
with International Affiliates, Medical Safety and Surveillance and Regulatory Affairs.
● Possesses knowledge of applicable regulatory standards and requirements for infant formula and
nutritional products.
Research Assistant, Nationwide Children’s Hospital Research Institute, April 2010 - July 2012:
● Performed Environmental Monitoring of Clinical Manufacturing Facility.
● Executed Endotoxin Assay, kinetic chromogenic method.
● Passed media fill qualification and assisted in Aseptic Fill for various drug lots.
● Performed accurate aseptic cell culture.
● Lead the CMF Cleaning Program; scheduled staff to perform different levels of cleaning necessary to
satisfy SOPs. Also included inventory, and stocking.
● Interviewed, hired, Trained and Supervised FWS students.
Resume of P.A.Whitaker
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● 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 PD
reports.
● Performed cGMP processes for the production of various Phase 1 Clinical Trial Gene Therapy Drugs.
● Originated Technical Writing including; training event documentation, SOPs, SPRs, SDRs, IQs, OQs,
RAs, revised MBRs.
Quality Assurance Technician, American Health Packaging, March 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.
● 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.
● Finalized Batch Records for auditor approval and product release.
Laboratory Technician, Sexing Technologies, Feb 2006 - April 2008:
● Prepared Samples Aseptically, including dilutions, and timing.
● Experienced using serological and micropipettes.
● Skilled specimen processing including; centrifugation, decanting, controlled rate freezing and
organization.
● Performed troubleshooting and operation of different equipment including;
nucleocounter, spectrophotometer, densimeter, coolers, liquid nitrogen freezers.
● Prepared enrichment media, fluorescing stain, and bacterial cultures.
● Evaluated cells using different microscopes.
● Efficient data entry and tracking.
● Trained and directed co-workers.
Special Skills: Advanced knowledge of; Excel, Microsoft Word, Internet Explorer, Outlook, Lotus Notes,
developed and successfully utilized spreadsheets for Ordering Lab Supplies, excellent interpersonal skills
with coworkers and management, reliable worker with thirst for new skills, excellent time management
skills.
References:
References available upon request.
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