Associate Director Quality Assurance

• Aug 2022 - Present

Clinical Quality Assurance Consultant

• Jan 2022 - Aug 2022

CMC Document Control Manager

• Sep 2019 - Jan 2022

Sr. Quality Assurance Associate

• Mar 2018 - Oct 2018

• Manufacturing QA support and clinical batch review / release. • Oversaw discrepancy management system. • Reviewed and approved validation documentation. • Performed raw material release. • Revised SOPs to improve quality system processes. • Manufacturing QA support and clinical batch review / release. • Oversaw discrepancy management system. • Reviewed and approved validation documentation. • Performed raw material release. • Revised SOPs to improve quality system processes.

Technical Content Writer

• Nov 2017 - Mar 2018

• Wrote new, and improved existing scientific content for NTP’s website, adhering to specific guidelines and AP Stylebook. • Lead meetings with stakeholders to communicate project goals and obtain updated content. • Explained technical ideas in user friendly language for a wide range of audiences. • Wrote new, and improved existing scientific content for NTP’s website, adhering to specific guidelines and AP Stylebook. • Lead meetings with stakeholders to communicate project goals and obtain updated content. • Explained technical ideas in user friendly language for a wide range of audiences.

Sr. Quality Assurance Associate

• Aug 2015 - Nov 2017

•Initiated, investigated and closed out Deviations, Change Control Requests, and CAPAs. •Implemented and managed all aspects of the controlled documentation system and records management. •Responsible for clinical lot release including batch record review, labeling/quarantine final product, and shipping. •Assisted with developing quality systems processes and documentation. •Maintained cell inventory in accordance with CFR 1271 regulations. •Performed internal and external… Show more •Initiated, investigated and closed out Deviations, Change Control Requests, and CAPAs. •Implemented and managed all aspects of the controlled documentation system and records management. •Responsible for clinical lot release including batch record review, labeling/quarantine final product, and shipping. •Assisted with developing quality systems processes and documentation. •Maintained cell inventory in accordance with CFR 1271 regulations. •Performed internal and external audits.

Quality Assurance Specialist II

• Feb 2013 - Jul 2015

Sourcing Documentation Specialist

• Nov 2010 - Dec 2011

• Wrote and edited Process Change Controls, Deviations and CAPAs for vendor and/or material changes. • Oversaw and completed procurement changes in the timeframe allotted per production schedule. • Owned and managed all department SOPs, document change updates, and periodic reviews. • Created new consumable raw material specifications. • Facilitated process improvements (i.e. Value Stream Mapping). • Wrote and edited Process Change Controls, Deviations and CAPAs for vendor and/or material changes. • Oversaw and completed procurement changes in the timeframe allotted per production schedule. • Owned and managed all department SOPs, document change updates, and periodic reviews. • Created new consumable raw material specifications. • Facilitated process improvements (i.e. Value Stream Mapping).

Documentation Specialist

• Sep 2009 - Sep 2010

• Managed and supported all aspects of controlled, GMP documentation within the organization, including policies, procedures, laboratory notebooks and training records. • Responsible for the receiving and release process of raw materials. • Wrote, edited, and formatted new and existing documentation. • Batch record issuing and archiving. • Developed new QA procedures. • Created MS Access database to house document revision / status information. • Managed and supported all aspects of controlled, GMP documentation within the organization, including policies, procedures, laboratory notebooks and training records. • Responsible for the receiving and release process of raw materials. • Wrote, edited, and formatted new and existing documentation. • Batch record issuing and archiving. • Developed new QA procedures. • Created MS Access database to house document revision / status information.

Process Technical Writer/Editor

• Apr 2006 - Oct 2008

• Wrote, edited, and formatted new Manufacturing Batch Records. • Revised existing Manufacturing Batch Records prior to manufacturing product runs. • Drove document deadlines by project schedule maintenance and serving as a key member of project teams. • Managed and implemented batch record document template. • Wrote, edited, and formatted new Manufacturing Batch Records. • Revised existing Manufacturing Batch Records prior to manufacturing product runs. • Drove document deadlines by project schedule maintenance and serving as a key member of project teams. • Managed and implemented batch record document template.

Documentation Specialist II

• 2001 - 2006