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- The QA Documentation Control Specialist II is responsible for the maintenance of the cGMP-controlled documentation system and for providing the various client's 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
- BA or BS in a related discipline
- Equivalent experience may be considered.
Quality Document Control Specialist - Novato, United States - Talent Software Services
