Senior Quality Assurance Associate

Company: Barrington James
Location: Bedford
Posted on: May 16, 2022

Job Description:

Overview The QA Senior Associate - GXP Auditing and Compliance is responsible for: Performing GxP QA internal / external auditing activities Supporting quality assurance activities to ensure company processes are compliant against the applicable regulatory requirements, guidelines, standards, agreements and/or SOPs. Ensuring the company is always inspection ready. Responsibilities Assisting in the development of a risk based GxP auditing program by: Planning and conducting audits of GxP suppliers and other external parties. Planning and conducting internal GxP audits of applicable internal processes to ensure compliance with applicable requirements and to help facilitate continuous improvement. Writing and distributing audit reports. Performing audit follow-up activities including assessment of auditee responses as well as agreed upon corrective actions. Support the company's Quality Management System (QMS) by assisting with the development and updating of standard operating procedures and other controlled documents. Providing compliance advice / support to the relevant GxP functional areas Assisting with the development, monitoring and reporting on quality assurance and compliance metrics. Support GxP inspection readiness activities as needed. Performing other duties as assigned. Qualifications Bachelor---s degree in Life Sciences or equivalent At least 5 years--- experience in the pharmaceutical / biopharmaceutical industry Strong GxP auditing experience Excellent knowledge of GxP regulations and guidance, as well as international requirements and standards Strong interpersonal, negotiation and communication skills Strong writing skills Well-organized, meticulous and thorough

Keywords: Barrington James, Boston , Senior Quality Assurance Associate, Other , Bedford, Massachusetts