Functional Skills
Industry Expertise
Software Skills
Microsoft Office
Sector Experience
Life Sciences & Pharma
Experience
Pernicus, LLC
Management Consulting
QA and RA
2/2019 - Present
Develop and implement Quality Systems (write SOPs for RA and QA; handle product complaint, adverse events and serious adverse event reports; and interface with the FDA. Review and release products, perform audits of manufacturers and distributors, and review promotional material per FDA and FTC guidelines and regulations. Have experience writing Clinical Evaluation Plans and Clinical Evaluation Reports for MDR.
MoonStone Consultants LLC
Management Consulting
QA
11/2014 - 7/2021
Responsible for the development and implementation of the Quality Systems, including, but not limited to, writing SOPs for regulatory affairs and quality assurance functions; designing, implementing, and maintaining a database to capture product complaint, adverse event and serious adverse event information; and interfacing with the FDA, when necessary.
Advisys, Inc.
Other
QA, RA and documentation specialist
1/2002 - 4/2006
Developed and maintained Qualify System. Developed clinical protocols and case report forms. Monitored and audited clinical trials. Performed internal investiations and audits.
Mannatech
Other
QA and RA
5/1995 - 1/1999
Clinical research development. SOP development. Wrote papers, abstracts and poster presentations.