QA Document Control Specialist

Passionate about precision medicine and advancing the healthcare industry?

Recent advancements in underlying technology have finally made it possible for AI to impact clinical care in a meaningful way. Tempus’ proprietary platform connects an entire ecosystem of real-world evidence to deliver real-time, actionable insights to physicians, providing critical information about the right treatments for the right patients, at the right time.

and continuous improvement of Document Management and Controls across multiple sites and business acquisitions. This position ensures that the Document Controls processes are in compliance with CAP/CLIA, FDA regulations, ISO and other regulatory standards. You will report to the Document Control Manager and will play a key role in ensuring document control compliance to applicable global regulations and standards. This will be a hybrid role.    

Responsibilities:

• Manage and maintain controlled documents  within the electronic Document Management System (eDMS) across sites and acquisitions to ensure compliance to applicable internal procedures, global regulatory requirements, and standards.
• Support the creation, revision,, obsolescence, review and approval of controlled documents, including procedures, work instructions, protocols, templates and technical documents.
• Collaborate with cross-functional partners such as Laboratory Operations, R&D, Regulatory, Medical Affairs, etc. to ensure timely document reviews and approvals.
• Become extremely well-versed in the electronic Document Management system to facilitate compliant reviews and approvals.
• Support the implementation of electronic Document Management solutions with a primary focus on Document Management and Control. 
• Assist in quality metrics related to Document Management and Control, providing reports as necessary.
• Support continuous improvements in the eDMS as well as document management and control processes.
• Collaborate with cross-functional partners to develop usable and compliant procedures, serving as a subject matter expert in regulatory compliance audits and inspections.
• Support audit actions and CAPA’s associated with the Document Management and Control.
• Support Document Control’s compliance with CAP/CLIA and FDA regulations, as well as ISO and other applicable regulatory standards.
• Support leadership on building efficiencies within Document Management and Controls. 
• Provide training and support on the use of eDMS and document control processes as needed.
• Other duties and projects, as assigned

Required Education & Experience:

• Requires a Bachelor’s degree or equivalent related experience
• 2+ years of experience in a Document Control or Quality Assurance role within a regulated environment
• Experience working in  electronic document management systems
• Experience working in a medical device, clinical laboratory, or other regulated environment.
• Intermediate computer skills and software applications, including experience with Microsoft Office tools (Outlook, Word, Excel, PowerPoint) or Google Suite applications
• Proven experience in working in a cross-functional team environment as well as the ability to function independently
• Strong written and oral communication skills, strong attention to detail, and organized
• Ability to work both independently and collaboratively
• Ability to be open-minded and adaptable with forward-thinking mindset 

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