Jennifer Zagata is a Quality Assurance Consultant with Zagata Associates, a company she formed which offers Pharma/Biotech Quality Assurance (QA) solutions that focus on Good Laboratory Practices (GLP) and quality systems.
Her experience in the pharma/biotech industry goes back over 18 years to when she worked at Schering-Plough as an Assistant Scientist in Histology/Necropsy. From there she moved on to Data Assurance providing quality control for pathology data and reports. Shortly after, Jennifer accepted the position of Compliance Specialist in the GLP Quality Assurance Unit. While there she was involved in all aspects of auditing nonclinical GLP studies, including critical phase inspections, data/reports, qualifications / validations, facility audits and Contract Research Organization (CRO) qualifications / inspections. She also participated in FDA inspections, corporate audits, and provided GLP systems guidance.
As Jennifer's career progressed she was promoted to Operations Manager of the GLP QAU. She helped establish the GLP QAU at a new site, facilitated FDA inspections, acted as the quality subject matter expert on clinical vendor qualification audits, and managed the revision of a GLP QAU training program for the auditing staff.
Jennifer has been consulting for over five years now and has had a variety of pharmaceutical and biotech companies as her clients. Projects she is involved with include: clinical vendor qualifications;
GLP bioanalytical and toxicology vendor audits; SOP development;
mock FDA inspections; NDA reviews; gap analysis and data/report auditing.
Many attribute Jennifer's success in this business to her ability to totally dedicate herself to the task at hand. She is ever vigilant about time-lines and is meticulous about her work, down to the smallest detail. She is very knowledgeable about her field, and enjoys sharing this knowledge
with others. People like to work with Jennifer and appreciate her logical and diplomatic thinking. Read what people are saying about Jennifer.
Education and Professional Affiliations:
- Bachelor of Science in Biology, Boston College;
- Basic Certificate in Quality Assurance / Regulatory Affairs, Temple University;
- Member of the Society of Quality Assurance;
- Participated in a Career Development Panel at SQA Annual Conference, April 2010.
Jennifer is an avid runner, she has run several marathons and numerous half-marathons. She enjoys traveling and spending time with her husband, their two daughters and their rescue dog, Morgan. Jennifer
was a long time New Jersey native but recently relocated to Houston,
Curriculum vitae available upon request.
You can email Jennifer now at email@example.com