Find your next job at a growing startup

201
companies
2,985
Jobs

QA Document Control Specialist

Tempus

Tempus

Quality Assurance
Chicago, IL, USA
Posted on Tuesday, September 19, 2023

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.


As Document Control Specialist, you will support the development, effective implementation,
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.

Responsibilities:

  • Support the administration of the electronic Document Management System across sites
    and acquisitions to ensure compliance to applicable internal procedures, global
    regulatory requirements, and standards.
  • Support update, review and approval of controlled documents, including procedures,
    work instructions, protocols, templates and technical documents.
  • Become extremely well-versed in the electronic Document Management system to
    facilitate compliant reviews and approvals
  • Support implementation Document Management solutions with a primary focus on
    Document Control and records management.
  • Support quality metrics related to Document Management and Control, providing reports
    as necessary.
  • Support continuous improvement to support a sustainable framework for QMS document
    control activities to enable simplification and standardization.
  • 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 Controls compliance with CAP/CLIA and FDA regulations, as well as
    ISO and other regulatory standards.
  • Collaborate with cross-functional partners such as Lab Operations, R&D, Regulatory,
    Medical Affairs, etc. to seek ensure timely document reviews and approvals
  • Support leadership on building efficiencies within Document Management and Controls.
  • Other duties and projects, as assigned

Required Education & Experience:

  • Requires a Bachelor's degree or equivalent related experience, 2+ years of experience
    in a documentation-related position in a regulated environment
  • Strong written and oral communication skills, attention to detail, and organized
  • Experience with working in an 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
  • Ability to be open-minded, define and create solutions to challenges or opportunities
  • Ability to communicate with all levels of technical and operations personnel
  • Ability to gather and organize information
  • Ability to create processes and workflows
#LI-SH1
#LI-Hybrid

We are an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.