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 penmanshipOrganizational skills to coordinate multi-discipline projects
Experience in participation in regulatory inspections a plus
Understanding and familiarity with FDA and European regulatory requirements, guidelines