Quality Document Control Specialist

Quality Document Control Specialist Job ID: 24-02189 Onsite with Hybrid option after training

The QA Documentation Control Specialist II is responsible for the maintenance of the cGMP controlled documentation system and for providing the various * departments the documentation that is necessary to perform cGxP activities. Other responsibilities include auditing existing documentation, reporting document trends to management, and managing electronic document systems.

Process requests for document changes utilizing the EDMS

Process document Special Handling requests

Provide department metrics to management

Participate in documentation audits

Process logbook requests and perform routine audits

Process laboratory notebook requests

Responsible for maintaining Archive Room: filing, assisting customers

Identifies improvements with group-level impact

Manages assigned work and takes on additional responsibilities

Involved with other projects as required

Preferred experience in auditing documentation

Proficiency in MS Word & MS Excel. Livelink and MS Access a plus

Ability to communicate clearly and effectively through verbal and type-written correspondence

Legible penmanship

Organizational skills to coordinate multi-discipline projects

Experience in participation in regulatory inspections a plus

Understanding and familiarity with FDA and European regulatory requirements, guidelines

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