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Work Background
EMMA InternationalPharmaceutical Investigations
Mar. 2023
Compliance InsightQuality Assurance/Regulatory Compliance Consultant
Apr. 2022 - Oct. 2022Thousand Oaks, California, United StatesProvided support to Atara Biotherapeutics (Atara) during and post EU pre-approval inspection (PAI). The inspection was successful and allows Atara to manufacture T-cell immunotherapy for EBV-associated ultra-rare diseases, EBV T-cell immunotherapy for progressive Multiple Sclerosis, Mesothelin CAR T for solid tumors, and nest-generation off-the-shelf allogenic CAR+ EBV T-cell immunotherapy. Performed quality-related SOP audits to include:
• Change Control
• Deviations
• CAPAs
• Internal Audits
• Document Control
• Non-conformances
• Training Worked with supplier quality to ensure the selection, evaluation, and qualification of suppliers and materials for the manufacture of therapies. Managed External Quality while the Sr. Manager was on leave. Provided tracking and successful completion of external laboratory analyses. Managed shipping, laboratory events, deviations, laboratory issues, and Certificates of Analysis (CoAs) for the successful completion of the laboratory analyses. Provided quality support to the Director of External Quality.
ICON plcProduct Compliance Scientist at ICON PLC
Aug. 2019 - Apr. 2022Frederick, Maryland, United StatesEmployed as a Product Compliance Scientist ensuring manufacturing and investigational product compliance for the Office of Regulated Activities, U.S. Army Medical Research and Development Command. Our mission is to provide manufacturing (GMP), nonclinical (GLP), and clinical (GCP) FDA regulated support and compliance for The Surgeon General-Department of the Army sponsored and funded investigational medical products (drugs, biologics, and devices). I provided manufacturing and product support services to Integrated Product Teams (IPTs) where safety is of utmost importance for clinical trials and manufacturing of product. I prepared product and manufacturing related documents and reports, performed site inspections, investigated manufacturing and product non-compliance, and worked with a team of experts in the regulatory field, ultimately providing investigation new drug (IND), new drug applications (NDA), and investigational device exemption (IDE) applications to the FDA. The IPT works with private industries and universities to bring awarded companies through the process of research and development, clinical studies, and finally through the full manufacturing process. Ensured compliance with cGLPs, cGCPs and cGMPs for investigational drugs, biologics, and medical device products. Assisted in the development of clinical trials assuring compliance to GCPs. Wrote and reviewed CMC (Chemistry, Manufacturing, and Controls) documents for regulatory IND, IDE, and NDA submissions. Performed clinical site audits for compliance to GCPs. Ensured proper storage and accurate records of the investigation product were maintained at the manufacturing site, storage facility, and clinical site. Reviewed batch records, release testing, stability protocols, validation plans, and reports.
Reviewed laboratory testing from validation and verification documentation through final instrument analysis results. Reviewed investigational product shipping qualifications and validations.
Pinnaql Inc.Sr. Validation Consultant
Mar. 2019 - Aug. 2019Malvern, PASr. Validation Engineer at Janssen Pharmaceuticals
Alaka`ina Foundation Family of CompaniesBiodefense Validation Engineer
Oct. 2016 - Aug. 2019Ft. Detrick, Frederick MDLead equipment/analytical instrument validation engineer at USAMRIID. GLP validation.
IPSConsultant at GSK
Mar. 2016 - Oct. 2016Marietta, PA
Johnson & JohnsonCompliance Specialist, Contractor
Apr. 2015 - Dec. 2015Lancaster, PAMs. Jacoby provided compliance support for instrument lifecycle management. She prepared, revised, and implemented IQ, OQ, and PQ validation protocols and reports according to GMP guidelines, ensuring execution and documentation of the qualification process for the laboratory equipment to include GC, HPLC, LC-MS, TLC, and dissolution. As well as validation support Ms. Jacoby:
• Supported lab operations team by preparing technical documents such as SOPs, qualification protocols, change controls, periodic reviews.
• Coordinated with lab ops team to prioritize projects according to a shifting need.
• Maintained compliance requirements for established instrumentation in the lab as well as incoming instrumentation.
• Worked in a cross-functional team to support lifecycle qualifications, commissioning, and decommissioning of instruments and equipment in the laboratory.
• Performed all duties per cGMP requirements with the ability to follow written SOPs and compendia procedures.
• Knowledgeable of common instruments and equipment used in an analytical laboratory.
• Provided authoring support for investigations as needed.
• Coordinated with lab ops team to provide training support and documentation for new equipment and instruments to laboratory staff.
• Maintained a high level of error free, GMP compliant documentation
Battelle Memorial InstituteResearch Scientist
Mar. 2002 - Jun. 2013APGEA, MDMs. Jacoby worked for Battelle as a Research Scientist for 12+ years before transitioning to the pharmaceutical industry. With Battelle, she worked on several special projects. Please view the "Projects" section of Ms. Jacoby's profile.
Alfred UniversityResearch Assistant
Sep. 1999 - Dec. 2001Alfred, NYMs. Jacoby received a fully funded research assistantship to Alfred University where she worked as a research assistant to the chair of the biomedical materials engineering science program. Her research focused on the dissolution of glass fibers in extracellular matrix. The purpose was to compare fiberglass fibers and manufacturing processes to see if, in fact, there was a breakdown of the fiber over time within the extracelluar matrix. The ultimate goal was to determine a more viable approach to research the affects of fiberglass on the lungs.
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