David Jolson Email & Phone Number

Chicago, IL, US

Chicago, Illinois, US

• Reviews all manufacturing batch records and QC test results. Ensures deviations were initiated and/or referenced as appropriate. Approves documents after verifying compliance with specifications and procedures.
• Reviews and approves Validation and Technical reports. Ensures protocol requirements were met and any exceptions were identified and approved. Teams with authors and SMEs to complete corrections/ resolve issues. Tracks.
• Conducts assessments of quality systems, identifies and closes gaps related to validation and corporate procedures.
• Triages, reviews and assesses Deviations and CAPAs, providing comprehensive impact assessments; Assist initiator with content, requirements and approvals. Ensure adherence to requirements for management closure review.
• Developed and Validated 6 analytical assays supporting biologic intermediate and combination device product lines, facilitating tech transfer to QC.
• Conducts quality assurance audits for critical logbooks, quarterly inspections of classified areas, and personnel training records.

Brooklyn, New York, US

• MD candidate clinical researcher at Dr. Evan Grossman gastroenterology lab.
• Investigated the role of regenerating islet-derived proteins in inflammatory bowel disease and targeted Atf6 as a potential strategy for Acute Pancreatitis treatment
• Conducted comprehensive research and medical writing, resulting in the successful publication of 3 research papers and creation of 7 abstracts and manuscripts.
• Ensured a GCP compliant environment by conducting thorough QA review for all publications.

IT

• Management of projects that ensure compliance with company guidelines.
• Act as quality resource and liaison to Operations.
• Oversee activities related to cGMP production operations.
• Management of deviations/investigations and monitor implementation of CAPAs.
• Hosted two FDA audits and three Internal Audits.
• Supported continuous improvement of the Trial Master File (TMF) for 2 orphan drug treatments through frequent auditing and ensuring proper eCTD submissions.

IT

• Increased RhoGam production by over 35% through the addition of 2 large-scale vessels and CIP systems in the fractionation facility.
• Batch Record review.
• Reviewed of all manufacturing documentation for completeness and accuracy.
• Ensured GMP and GDP are followed.
• Entered critical batch record information into validated databases and spreadsheets.
• Investigated and reported all process deviations during product manufacturing.

Ann Arbor, Michigan, US

-Mouse cell culture studying osteogenesis utilizing different pathogens and protein identification in a craniofacial surgical lab.-Investigated the mechanisms underlying pediatric craniofacial anomalies, such as craniosynostosis and cranial suture morphogenesis.-Evaluated distraction osteogenesis as a strategy to potentially mitigate the damage to bone in.

US

Pasadena, California, US

-Student mentor for Anesthesia department-Spent one week in many different sections of the hospital that needed an anesthetist, such as orthopedics, urology, gastroenterology, maternity, neurology, cardiology and more-Observe many different surgeries from the perspective of an anesthetist

Bachelor'S Degree, Cell And Molecular Biology

Doctor Of Medicine - Md