Personal Information
Organization / Workplace
Greater Boston Area United States
Occupation
Senior Quality Assurance Specialist GCP at Merrimack Pharmaceuticals
Industry
Medical / Health Care / Pharmaceuticals
About
Professional Summary:
GxP professional with experience, formal education and training in:
• Conducting GxP audits to ensure compliance with global regulations and current industry expectations
• Working with staff to develop, implement, track, and closeout Corrective and Preventive Actions in a timely manner.
• Preparing and overseeing FDA, OHRP and IRB submissions to support the development and regulatory approval of new drugs, biologics and medical devices.
• Interpreting global regulations and guidelines pertaining to GCP, GLPs, GMPs
• Authoring and implementing site-wide SOPs to ensure compliance with GxP regulations
• Developing and delivering training on GCPs, GMPs and
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