Jennifer J.

Experience

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  Nitto Avecia

  Jan 2001 - Jan 2004

  Quality Assurance Specialist/Manufacturing Compliance

  ● Released raw materials for in process use. ● Reviewed batch records and released API. ● Maintained statistical process control database.● Performed internal audits

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  Lonza

  Jan 2005 - Jan 2011

  Quality Systems Compliance Specialist II

  ● Managed TrackWise database, metrics, trends and training. ● Initiated, tracked and closed internal and external audit CAPAs. ● Managed change controls, Lonza and Client driven changes. ● Investigated all routine and dynamic EM excursions.● Initiated a mold prevention program.● Published and presented quarterly site quality metrics to Site Leadership.● Backroom team member, EMEA, FDA, client audits● Harmonized SOPs between site and global level.

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  Sanofi

  Jan 2011 - Jan 2013

  Sr. Compliance Specialist

  ● Managed the lot release process – lot trees, CoAs, LIMS results, Deviations, Lab Investigation, EM investigations.● Team member, Drug Substance Release Improvement Initiative – Mapped process improvements, 50 day drug release process.● Visual Management Board Owner, tracked on time progress of drug release. ● Managed the Action Notice process for controlled areas and critical utility work orders● Tracked and documented metrics – batch record observations from consultants. Show less

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  Alexion Pharmaceuticals, Inc.

  Apr 2013 - Apr 2017

  QA Specialist III

  ● Responsible for vendor management program and raw material qualification activities.● Responsible for managing supplier change notifications to determine site impact.● Coordinate resolution of raw material quality issues with vendor, purchasing and logistics. ● Member of Raw Material Review Committee, Kaizen Process Improvement Team.● Owner of the Raw Material Change Management Meeting.● Manage supplier investigations for defective raw materials.● Developed site-wide predictive and preventive maintenance program. ● QA contact for deviations, CAPAs, change controls, Effectiveness checks, SOP revisions, work orders, critical alarms, OOTs.● Author chapters for Annual Product Review of commercial drug product. ● Initiate and solicit vendor response and approvals of Quality Agreements. ● Track and trend quarterly quality metrics. Show less

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  Corbus Pharmaceuticals

  May 2017 - now

  • Quality Assurance Project Manager

    Jul 2019 - now

  • Sr. QA Specialist

    May 2017 - now
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  Sarepta Therapeutics

  Apr 2022 - now

  Quality Assurance Manager