Ingrid Annan, MS

Experience

• 

  Eon Labs

  Apr 2001 - May 2005

  •Responsible for technical writing of raw material and finished products testing methods, monographs, and specification sheets for quality control and research and development.•Successfully audited reconciliation records to track controlled drugs.•Performed a detailed review of the annual product review list to capture Quality Assurance or Quality Control investigations and alert level notices.•Maintained and distributed Material Safety Data Sheets. •Routinely audited laboratory notebooks, including reviewing chemists’ calculations, chromatograms, and data as per the USP. Confirmed that the chemist followed proper procedure and verified the test results met established test specifications.•Worked closely with Quality Control to ensure all lots released met established test specifications.

  • Quality Control /Documentation Specialist

    Nov 2002 - May 2005

  • Quality Assurance / Auditor

    Apr 2001 - Oct 2002
• 

  OSI Pharmaceuticals

  Oct 2005 - Jun 2011

  •Provided support in managing clinical trials.•Collaborated with various third party vendors to ensure adequate supplies for ongoing clinical studies.•Frequently scheduled labeling jobs with third party vendors.•Performed monthly inventory reconciliation for all clinical supplies at various distribution and packaging facilities. • Performed Oracle Process Management for new development compounds.• Reviewed material shipment requests. •Regularly coordinated distribution of clinical trial supplies for global studies utilizing both manual and electronic systems.•Processed requests to mobilize material from GMP storage facilities.•Routinely monitored IVRS requests.•Actively worked with third party vendors and international depots to ensure proper distribution of supplies to clinical sites.•Processed inquiries from clinical sites and clinical research groups regarding shipments of supplies.

  • Clinical Trial Supplies Associate

    Jan 2008 - Jun 2011

  • Clinical Trial Supplies Coordinator

    Oct 2005 - Dec 2007
• 

  Regeneron

  Jun 2011 - now

  •Clinical Drug Supply & Logistics Lead for investigator initiated studies•Forecasts and ensures on time delivery of clinical supplies•Coordinates the review, approval and generation of clinical label text and medication kit list for clinical supplies•Interfaces with QA and Regulatory Compliance to support the release of clinical supplies and obtain documentation required for regulatory submissions as needed•Manage IRT activities as it relates to clinical supply activities for IP releases and order management Show less •Provides support in managing global clinical trials.•Experience with working with multiple IRT systems.•Manage IRT activities such as Inventory Releases, QP Management and Order Management.•Ensures appropriate documentation of investigational product supply activities are filed in the Trial Master File. •Experience in supporting FDA Inspections.•Closely reviews and evaluates temperature excursion data and communicates stability information to clinical trial managers, CROs and investigator sites; provides assessments to supply management team.•Initiate investigational product shipment orders; communicates with distribution vendors to ensure timely and compliant shipment and delivery to investigator sites.•Support continuous improvement initiatives within Clinical Logistics.•Train and mentor junior staff. Show less •Provides support in managing global clinical trials.•Monitors investigational product expiry data and informs Clinical Teams of upcoming investigational product expiry.•Ensures appropriate documentation of investigational product supply activities is provided to clinical trial teams for the Trial Master File. •Closely reviews and evaluates temperature excursion data and communicates stability information to clinical trial managers, CROs and investigator sites; provides assessments to supply management team.•Initiate investigational product shipment orders; communicates with distribution vendors to ensure timely and compliant shipment and delivery to investigator sites. •Facilitates ancillary supply shipments to investigator sites; develop plans for supplying clinical study sites, either through in-house initiated supply or working with supply vendors. Show less

  • Associate Manager

    Jan 2022 - now

  • Clinical Logistics Associate II

    Jan 2014 - Dec 2021

  • Clinical Logistics Associate

    Jun 2011 - Dec 2013