Document Control Specialist
Carla Woolever
@carlawoolever
Quality Assurance Document Control Specialist ensuring compliance and process efficiency.
What I'm looking for
As a dedicated Quality Assurance Document Control Specialist, I bring a strong background in maintaining accurate and compliant documentation systems. My expertise includes implementing robust document control processes, training staff, and ensuring adherence to regulatory standards such as ISO13485:2016.
In my roles at QMS, Cue Health, and Abbott, I successfully managed document control systems, led training programs, and collaborated with cross-functional teams to improve processes. I am certified in ISO13485:2016 and have a proven track record in cost avoidance and process improvements.
I am passionate about streamlining document management, ensuring regulatory compliance, and supporting audits to maintain high-quality standards. My experience includes working in fast-paced environments, both on-site and remotely, where attention to detail and efficient project management are crucial.
Experience
Work history, roles, and key accomplishments
Archivist Contractor
x4 Pharmaceuticals
Jul 2024 - Sep 2024 (2 months)
Assisted in the GxP Document and Records Management Program, serving as Subject Matter Expert in electronic document management systems. Maintained quality archiving and organization of electronic controlled documents, ensuring proper traceability in the QMS system.
QA Document Control Specialist
Cue Health
Apr 2021 - Feb 2024 (2 years 10 months)
Managed the change order and document control systems, supporting QMS with a comprehensive library of documents. Developed training programs on GDP and QMS procedures, and assisted in audits while ensuring regulatory compliance.
Quality Project Coordinator / Document Control
Abbott
Jul 2016 - Sep 2019 (3 years 2 months)
Implemented remote environmental validation processes, trained personnel on validation protocols, and maintained supplier qualifications. Ensured compliance with ISO13485 and managed documentation for QA and Operations.
Education
Degrees, certifications, and relevant coursework
Carla hasn't added their education
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