Experience

Agios Pharmaceuticals

• United States
• Pharmaceutical Manufacturing
• 300 - 400 Employee

• Senior QA Specialist

  • Oct 2020 - Present

  Responsible for the release of packaged IMP manufactured at CMO sites. Responsible for the release of packaged IMP manufactured at CMO sites.



The Janssen Pharmaceutical Companies of Johnson & Johnson

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Quality Assurance, R&D External Sourcing

  • Mar 2018 - Nov 2019

  Responsibility and QA oversight for the following processes for the management of assigned external supplier, including: • CMO qualification and governance; including site audits and Quality Agreements. Managed external contract manufacturers by providing Quality and cGMP oversight for assigned clinical projects. • Master batch record review/approval and approval of executed batch records for release to package for clinical product. • Ensure that all required documents for batch release are available for the QP. • Ensured effectiveness of CAPA’s for deviations with possible impact on quality, compliance, and registration are accurately investigated and corrective actions implemented to drive continuous quality system improvement. • Conduct routine joint Quality meetings with CMO's for tracking to completion of batch releases, change controls, deviation management and other QMS responsibilities. • Provide quality metrics for management review.



Astra Zeneca LP Us

• Global QA Specialist

  • Jan 2015 - Jun 2016

  Finished product release, consumer complaint investigations, deviation management Finished product release, consumer complaint investigations, deviation management



Astra Zeneca

• Wilmington, Delaware

• Senior QA Supplier Manager

  • Sep 2012 - Mar 2014

  Responsibility and QA oversight for the following processes for the management of assigned external suppliers, including: - Change Control - Documentation Managment - Lean Releaseand Deviation Management - Local Direct Material Supplier and Distribution Management - Quality Agreements -Complaints -Field Alerts/Stop Shipment Responsibility and QA oversight for the following processes for the management of assigned external suppliers, including: - Change Control - Documentation Managment - Lean Releaseand Deviation Management - Local Direct Material Supplier and Distribution Management - Quality Agreements -Complaints -Field Alerts/Stop Shipment



Parexel Pharmaceutical Management

• New Brunswick, New Jersey

• Data Integrity Auditor

  • May 2012 - Aug 2012

  Performed documentation audits of all completed NDA, ANDA, and CMC Annual Report submissions for data integrity evaluation. Verification of all calculations made during laboratory analysis. Ensured that all documents were relevant to justify conclusions. Performed documentation audits of all completed NDA, ANDA, and CMC Annual Report submissions for data integrity evaluation. Verification of all calculations made during laboratory analysis. Ensured that all documents were relevant to justify conclusions.



AstraZeneca

• United Kingdom
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Compliance Specialist

  • Apr 2007 - Nov 2009



GlaxoSmithKline Consumer Healthcare, L.P.

• United States
• Pharmaceutical Manufacturing
• 200 - 300 Employee

• Compliance Specialist

  • Feb 2004 - Mar 2005



Astra Zaneca

• Public Relations and Communications Services
• 1 - 100 Employee

• Compliance Specialist

  • Jun 1996 - Mar 1999



Schering Plough Phramaceutical

• Union, NewJersey

• Senior Corporate Compliance Specialist

  • Jun 1992 - Nov 1994



Rhone-Poulenc Rorer

• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Senior Compliance Auditor

  • Aug 1986 - Jun 1992

  • Performed periodic audits of internal departments, contract manufacturing and packaging sites for regulatory compliance. • Oversite for GMP/GLP audits, schedule, audit team, and monitoring of all outstanding audit findings for subsequent follow-up and resolution. • Responsible for QA/Compliance review of CMC section for Annual Product Reviews for all products manufactured in U.S. and Canada, including investigation of any discrepancies and subsequent revisions for year- end closure.