Amanda Feddersen, CQA

Experience

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  WIL Research Company, Inc.

  Nov 2004 - Feb 2008

  Biologist

  • Responsible for the performance of in-life phases of assigned agricultural product and general toxicology studies • Functioned as lead biologist for complex studies. • Conducted detailed clinical observations • Preformed advanced technical procedures.

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  Battelle

  Apr 2008 - May 2013

  Senior Research Technician

  • DOD S Clearance • Performing quality, safety, regulatory and compliance audits Producing reports for internal use and external (regulatory/industry) utilization• Knowledge of Project Management. • Knowledge of GLP/GMP guidelines• ISO 9001 Certified• Knowledge of CPRP and BPRP guidelines• Thorough knowledge of standard operating procedures (SOP) .• Sound knowledge of federal, state, and/or university regulations regarding animal care and use in research and teaching. • Able to explain policies, procedures, rules, and regulations; to supervise and train other employees; and to organize and prioritize work assignments. • BSL-2 and BSL-3 Experience• RLATG - AALAS Show less

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  The Ohio State University

  Nov 2013 - Jun 2015

  Researcher /Laboratory Manager

  Neurophysiology• Authoring of Standard Operating Procedures and Protocols• Maintenance of Laboratory Equipment, • Ordering of supplies, and Animal Procurement• Quality assurance and compliance with State and Federal Guidelines involving Research• Following Safety procedures • Keeping accurate, complete, up-to-date records of all work done. • Research Laboratory Management, Safety and Animal Skills training to staff involving the Non Human Primate• Keeping up to date training records for all staff Show less

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  Henry Schein Animal Health

  Jun 2015 - Nov 2019

  Quality Assurance Analyst II
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  Covetrus

  Jun 2015 - Nov 2019

  Quality Affairs Analyst II

  *CAPA writing, compliance and management *Authoring and Managing Standard Operating Procedures and Company wide training *Product complaints/ Adverse events management*Master Administrator of Document Control System, Power DMS*Master Administrator for company wide training platform, Litmos*Compliance with State and Federal regulation regarding distribution* Supports Internal and External Audits * Conducts International and Domestic Supplier Audits *Investigations/ Technical writing*Quality Management System* Auditing for ISO: 9001, GMP, GDP, FDA, DEA, OSHA, PDMA, and VAWD requirements. *Member of the American Society of Quality *Certified Quality Auditor Dec 2016 * Supplier Management/ Auditing Domestic/ Foreign Show less

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  Tosoh Bioscience, Inc.

  Nov 2019 - Jul 2021

  Quality Assurance Engineer

  *Non- Conformance Management *Supplier Management/ Auditing* Recall Coordinator * CAPA Management *Authoring SOP's * Trending *Compliance with ISO 13485/ MDSAP

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  Monitored Therapeutics, Inc.

  Jul 2021 - now

  Quality Assurance Manager
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  12th Man Technologies, Inc.

  Aug 2022 - now

  Quality Assurance Manager