This job is with Thermo Fisher Scientific, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.
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Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office
Job Description
As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
DESCRIPTION:

Assists in establishing current quality systems as they pertain to current industry, regulatory and customer requirements for investigational new drugs, biologics and/or medical devices and maintaining operations in a state of control. Also assists the QA Director in maintaining the established systems.
Establishes Standard Operating Procedures (SOP), performs routine maintenance of SOPs, including periodic reviews to assure alignment of systems with regulatory requirements and global requirements. Provides training when required to assure retention.
Audits departments for compliance to the quality systems, generating audit reports, identifying trends, and establishing performance of the quality system
Provides quality oversight of vendor qualifications, i.e. questionnaires, quality agreements, vendor audit schedule etc.
Maintains Change Control, Deviation, Out of Specification, Corrective and Preventative Action, Compl

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