Job Title Associate II/III, Quality Assurance Location US-MA-Cambridge Job Category Quality Requisition Number 13060BR Job Description The purpose of this position is to assist in the development and implementation of Global Quality Systems, to perform Quality review and approval for Cambridge site exceptions and CAPAs to ensure accuracy and compliance to applicable regulatory and corporate guidance documents, and to support internal and regulatory inspections as necessary. Additionally, this position is expected to act as an administrator for the Trackwise exception and CAPA system and provide training on the use of the system.
Responsibilities include:
1. Providing final Quality approval of exceptions and CAPAs (Alert/Action Reports, Deviations, Laboratory Exceptions, Remedial Action Reports, and Corrective and Preventative Actions) assuring accuracy and compliance to internal and GMP requirements.
2. Representing Quality Assurance on Cambridge site projects. Participating in global operational excellence projects and/or alignment activities. Participating on cross-functional teams at the site and/or global level.
3. Performing internal audits of controlled areas for GMP compliance and supporting regulatory inspections as necessary.
4. Supporting daily functions and lead team efforts for process improvement of exception systems.
5. Performing GxP quality systems-related trainings for the Cambridge site.
6. Reporting and trending monthly/quarterly metrics for exception closure. Qualifications Bachelor's Degree and 6+ years of technical Quality experience in a GMP regulated environment
Proficiency working with TrackWise Teamaccess (including Admin Module)
Proficiency in Microsoft Office Applications Education Bachelor's Degree
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