About Jennifer ─ a Brief Introduction & Overview

About Jennifer ─ a Brief Introduction & Overview

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), good clinical laboratory practices, and quality systems.

Her experience in the pharma/biotech industry goes back over 24 years to when she worked at Schering-Plough as an Assistant Scientist in Histology/Necropsy. She moved on to Data Assurance providing quality control for pathology data and reports. Shortly after, Jennifer accepted the Compliance Specialist position in the GLP Quality Assurance Unit.

While there, she was involved in 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 11 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 dedicate herself to her task. She is always vigilant about timelines and 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.

Education and Professional Affiliations

  • Bachelor of Science in Biology, Boston College;
  • Basic Certificate in Quality Assurance / Regulatory Affairs, Temple University;
  • Active Member of the Society of Quality Assurance;

Jennifer enjoys reading, playing golf, and watching the latest binge-worthy TV. She enjoys traveling and spending time with her husband, two daughters, and their rescue dog, Jax. Jennifer was a long-time New Jersey native but relocated to Houston, Texas in 2015.