Senior Quality Assurance Associate
Company: Barrington James
Location: Bedford
Posted on: May 16, 2022
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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
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