Experience

Boston Analytical

• United States
• Pharmaceutical Manufacturing
• 100 - 200 Employee

• QA Associate Director

  • Jul 2018 - Present

  Implementing and maintaining Quality systems and procedures in compliance with all current FDA GMP regulations and guidance, as well as relevant ICH guidelines. Manage quality operations and compliance functions, provide expertise and direction in relation to quality initiatives. Implementing and maintaining Quality systems and procedures in compliance with all current FDA GMP regulations and guidance, as well as relevant ICH guidelines. Manage quality operations and compliance functions, provide expertise and direction in relation to quality initiatives.



Pumaltrix Pharmaceutical Inc

• Quality Management System (QMS) Manager

  • Oct 2016 - Jul 2018

  Lead external (EU) audits for clinical investigations, Medical Devices, and internal process audits and/ or GCP documents audits to ensure compliance to the code of federal regulations, ICH and applicable regulations and laws and company internal policies. Coordinate and Trend stability data performed from CMOs/CROs and conducted audits regularly. Lead GCP Quality projects and working with teams to effectively initiate, plan, execute, monitor and close projects for multiple different programs. Lead external (EU) audits for clinical investigations, Medical Devices, and internal process audits and/ or GCP documents audits to ensure compliance to the code of federal regulations, ICH and applicable regulations and laws and company internal policies. Coordinate and Trend stability data performed from CMOs/CROs and conducted audits regularly. Lead GCP Quality projects and working with teams to effectively initiate, plan, execute, monitor and close projects for multiple different programs.



uniQure

• Netherlands
• Biotechnology Research
• 400 - 500 Employee

• Quality Assurance Lead

  • Sep 2015 - Oct 2016

  Perform routine reviews on manufacturing batch records and the associated analytical data and documents in support of product disposition in accordance with specifications and SOPs; generate disposition documentation. • Review and approve material and product specifications, Certificate of Analyses, stability protocols and data. • Make recommendations to Quality Assurance management for the disposition of drug product. • Perform reviews of Work Orders, Calibrations, and Engineering Change Requests relating to qualified Facilities, Utilities, Software systems and Equipment used in cGMP activities. • Create, review, and approve documents including Standard Operating Procedures, Metrics Reports and other documents, as required. • Assist QA with the Quality GxP training implementation on site. • Represent Quality Assurance at operational meetings. • Provide on-the-floor QA inspection oversight during GMP cleanroom production operations. • Review and approve Deviations, Investigations and Corrective and Preventive Actions (CAPA); including performing Failure Mode and Effect Analyses (risk assessments). • Participate in and/or lead root cause analysis investigations. • Review and approve Change Controls. • Provide inspection readiness support for third-party audits and regulatory inspections. • Assist with internal audits as necessary. • Perform other quality/operations related tasks, as required. Show less



Merrimack

• United States
• Biotechnology Research
• 1 - 100 Employee

• Sr. Compliance Specialist, Quality Assurance

  • Sep 2014 - Sep 2015

  Interface with and influence all manufacturing areas to continually improve quality. Perform real time manufacturing batch record review. Perform data review for disposition of bulk drug. Assure manufacturing operations are in compliance with GMP regulations. Leverage quality systems to support lot release and continuous improvement. Evaluate and approve quality incidents and CAPAs and work with key stake holders to support the closure. Provide critical review/approval of SOPs and material specifications. Initiate and/or assist departments with investigations related to manufactured products. Conduct and/or assist with GMP compliance training. Assist with disposition of bulk drug product. Perform walkthroughs and audits as required. Show less



Sanofi Genzyme

• Quality Assurance Associate

  • Feb 2011 - Sep 2014

  Ensure operation documentation meets established requirements for cGMPs, GLP, GMP. Review and approve completed batch documentation, productions records and associated logs for release. Responsible for ensuring compliance of manufacturing procedures to in-house specs and government regulations. Prepares product lot release documentation to support the product release team Conducts review of manufacturing processes to ensure compliance. Conducts review of testing results in support of release of intermediates. Responsible for final report review; assure compliance with regulations and industry standards. Show less



Biogen Idec

• Lab Tech III

  • 2007 - 2011

  Budget reconciliation for the animal facility laboratories, reporting to management. Provided coaching and mentoring to fellow employees. Responsible for procurement and receipt of animals and consumable supplies. Maintained supplies inventory. Budget reconciliation for the animal facility laboratories, reporting to management. Provided coaching and mentoring to fellow employees. Responsible for procurement and receipt of animals and consumable supplies. Maintained supplies inventory.



Harvard Medical School

• United States
• Higher Education
• 700 & Above Employee

• Lab Tech II

  • 2003 - 2007

  Responsible for animal procurement and inventory management Coordinated Audit/inspections Reporting, including inventory and post-audit analysis Responsible for animal procurement and inventory management Coordinated Audit/inspections Reporting, including inventory and post-audit analysis