Kimberly G. Email & Phone Number

Chapel Hill, Nc, Us

Radnor, Pennsylvania, Us

• Authors documents for submission to regulatory authorities including investigator's brochures (IBs), development safety update reports (DSURs), NDA summary documents (integrated summary of safety), briefing books and scientific advice, protocols, clinical study reports, and patient narratives.• Ensures documents are compliant with regulatory guidelines, client specifications and templates, internal SOPs and style guides, and other guidance documents.• Leads client teams through the document review process and conducts comment resolution meetings (CRMs) to address and align reviewers' comments.• Provides quality control (QC) review of documents for internal and external consistency, visual appearance, and grammar in order to provide clients with a complete, accurate, and consistent document.• Manages resources for projects in order to deliver the document within the project timeline and budget.• Maintains a client-focused, collaborative work environment that fosters open communication between the client and internal teams.• Mentors junior writers and new employees on company best practices and client-specific documents.• Coordinates resources for writers and technical editors between the global offices to ensure that project timelines are met.

Melbourne, Victoria, Au

• Certified as a Level I and Level II deviation investigator• Investigated OOS results for stability samples and documented the investigation in Sentry • Recommended and implemented CAPAs to prevent repetitive deviations and to improve processes• Assessed the impact to the stability study as a part of stability deviations• Attended daily commercial meetings to ensure that the bulk schedule and upcoming strain selections are effectively communicated to the stability group• Authored Stability Protocols and routed the document for approval in Atlas•Reviewed document revisions in Atlas•Revised SOPs in Atlas as specified in the CAPA •Participated in the global stability forum which implemented the Stability MSOP •Created Stability Test Articles and Stability Protocols in GLIMS which specified stability storage conditions and testing intervals•Managed the Stability Studies in GLIMS and performed stability monthly time point pulls per relevant stability SOPs•Implemented the Stability SharePoint site for use as a planning tool to notify the QC laboratories in Holly Springs and other Novartis sites of stability sample pulls, stability sample shipments, and to ensure that stability testing is completed within the required timelines•Planned and published the stability time point pull schedule for every product on stability to ensure on-time stability testing•Provided stability data to support HHS and audit activities•Coordinated sample shipments to contract laboratories and other Novartis sites•Aliquoted samples from manufacturing to distribute to the laboratories for testing•Utilized GLIMS and relevant SOPs to store, transport, and track samples•Issued, reconciled, and archived controlled documents•Attended several training classes at BTEC which covered aseptic manufacturing processes, controlled temperature environment qualifications, and risk based approaches to validation

Basel, Basel-Stadt, Ch

• Generated Stability Protocols to specify stability testing intervals and conditions• Created Stability Studies and entered data generated for the stability study into LIMS• Audited results, authorized, and released samples utilizing LIMS• Supported the completion of several CAPAs related to the QC Stability group• Created Method Validation Reports and Method Validation Protocols • Ensured all validation data was correctly documented, reported, and referenced• Obtained chromatograms using Empower software• Submitted documents for final approval to QA Compliance• Investigated method deviations and generated a report summarizing the investigation and any necessary corrective action• Formatted and revised validation reports to be consistent with current practices and as specified by management and pre-approval inspection (PAI) reports• Initiated Change Controls with justification using Trackwise• Revised monographs and methods according to the approved Change Controls

Wilmington, North Carolina, Us

•Experienced in USP, EP, JP, BP, FCC, and ACS monographs •Trained in IR and UV spectroscopy, pH, conductivity, gravimetric testing, elemental testing, and extractions •Formatted and generated client reports that summarized all data collected•Organized and archived all projects completed within the company•Proficient in using sample tracking software