"Over the past 5 years our quality group has come to rely on Jennifer’s auditing skills to help augment our GLP auditing capabilities. As Head of Quality for a small, fully virtual Biotech company I can tell you that auditing vendors is critical and Jennifer has helped us immensely in this area. She is very knowledgeable in the regulatory requirements, has a great work ethic, communicates well and delivers results on time and at the agreed price. A couple of things in particular that I appreciate is that she’s always available to provide quick advice and was able to adjust her reporting style to match ours. Overall I would say she is a highly polished professional and I would not hesitate to recommend her to anyone."
Gregory Birrer, Ph.D., Sr. Director and Head of Quality for Elusys Therapeutics, Inc.
"I have known Jennifer for over 15 years and have
worked with her in her role as a Scientist, QA auditor,
and QA Consultant. Most recently, she was our QA
Consultant for 3 years at Elusys Therapeutics, Inc., where
she provided Quality audits of CRO testing facilities,
Bioanalytical test sites, as well as audits of contributing
scientist and final reports for both nonclinical studies and
clinical trials under FDA GLP and Animal Rule
regulations. Combined with her scientific background,
her knowledge and experience in quality and compliance
are very impressive. She is always well-prepared, very
thorough and her audit reports are detailed, well written,
and always on time. In addition, because of her
professionalism and collaborative approach to auditing,
not only does she gain the respect of her peers but also
of the people she has audited. Jennifer continues to be a
great QA resource for me; when I have some compliance
issues that come up, I know that I can always reach out
to get her feedback. If another opportunity presents
itself that I would need a QA Consultant, I will not
hesitate to hire Jennifer again.”
Nestor Gonzales, GLP/GCP Quality Director, Elusys
"Jennifer conducted about 10 vendor audits on our behalf in just over a two month period. Despite these seemingly impossible timelines, she was always well prepared and performed a thorough audit at every site. Jennifer is intelligent, articulate, diligent, professional, extraordinarily organized, and an invaluable resource.
Her collaborative approach to auditing allowed her to identify risks and present her concerns in an understandable way that inspired corrective action at the laboratory/CRO often before the audit report was even issued. Her audit reports were always on-time or early, detailed, well-written, and focused on substantive audit findings.
I strongly recommend Jennifer and am confident that any organization can benefit from her expertise in GLP and clinical laboratory compliance."
Susan Greenbowe,Senior Manager, GXP Compliance & Auditing
"Jennifer Zagata was hired by my [biotech] company to perform QA qualifications on potential laboratory vendors to support our upcoming clinical programs. As my company's clinical operations representative, I accompanied her on eight such visits within a two-month period and was consistently amazed by her knowledge, the application of her QA experience, and the thoroughness through which she performed the audits. We relied on her expertise to tease out the strengths and weaknesses in each organization's quality infrastructure and she was equally adept at relating their SOPs with actual laboratory practices. Her professionalism continued in the follow-up to these visits; her audit reports are detailed, well-presented, and on-time. I personally enjoyed the experiences of this collaboration and hope there is opportunity for more interactions in the future."
Francis C. Payumo, MS, EMT-B, Lead CRA, Clinical Operations
"I have known Jennifer Zagata for almost ten years and in that time, I have had the opportunity to work with her in her role as auditor, manager, and QA consultant. From the beginning, she impressed me with her breadth of QA knowledge and understanding of the importance of compliance. She was always very well prepared as an auditor, and as she was promoted into a management role, she continued to impress with her organizational skills and ability to identify and address key compliance concerns. Never one to be passive or stagnant, Jennifer expanded her base from basic GLP auditing and project management to performing clinical laboratory qualifications. This expansion served her well as she went out on her own as a QA consultant and she has successfully conducted numerous CRO vendor assessments and evaluations. Combined with her experience in working with both FDA and OECD GLPs, Jennifer's skills in interfacing with her clients sets her far apart from her competitors. If I needed to hire a QA consultant, Jennifer would be the first one I called."
Kenneth Dammers, GLP Quality Assurance
"I have worked on numerous GLP studies with Jennifer Zagata of Zagata Associates. Jennifer is thorough, highly knowledgeable in GLP and FDA regulations, and very professional. I would highly recommend Jennifer as a quality assurance auditor."
Mary Barecki-Roach, M.S. (Pharmacokineticist)
ClinPharm Consulting, LLC, RTP, NC
"In 2011 I brought Jennifer into my company to perform an extremely challenging task on the recommendation of a long time trusted colleague. I had never met Jennifer before but trusted the good word I had heard about her performance. Immediately upon first contact I was very impressed with her compliance knowledge, professionalism, and drive to accomplish all that was asked of her to the highest quality. The amount of work and aggressive timelines did not deter her and the deliverables were on time every time. More importantly, the quality of both her interpersonal interactions and the reports provided to me were impeccable. I highly recommend Jennifer."
Shaun Kenny, Compliance Director, GLP Strategy, Global Compliance Auditing (GCA), Global R&D Compliance
You can email Jennifer now at email@example.com.