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Carla Woolever

@carlawoolever

Quality Assurance Document Control Specialist ensuring compliance and process efficiency.

United States

What I'm looking for

Document Control Specialist

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

XP

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.

CH

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.

Education

Degrees, certifications, and relevant coursework

Carla hasn't added their education

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Tech stack

Software and tools used professionally

Availability

Looking for a job

Location

United States

Authorized to work in

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Carla Woolever - Archivist Contractor - x4 Pharmaceuticals | Himalayas