Document Control Analyst
JR000011665 Document Control Analyst (Open)
US Specialty Brand Headquarters - USA501
This position establishes and performs document control processes to ensure that controlled documents are revised, approved, distributed, and archived using Master Control.
- Manage the document control process in Master Control.
- Review Document Change Controls for completeness and correctness. Ensure that appropriate approvers are specified. Collaborate with change originators to resolve discrepancies.
- Perform final formatting on revised documents to ensure accurate incorporation of redline revisions.
- Promote approved documents to effective upon completion of required training and any change control requirements.
- Monitor the periodic review process of controlled documents for timely completion.
- Train new users when required in the use of the Master Control Document Control module.
- Maintain user profiles with appropriate access rights.
- Communicate any EDMS issues with Master Control.
- Serve as the subject matter expert to end users of the Master Control Document Module.
- Manage the relationship between document change controls and change controls.
- Manage document reports.
- Support all regulatory audits and inspections.
Education / Experience / Skills:
- BA/BS Degree
- 2-4 years of experience in a medical device (Class II/Class III) and/or pharmaceutical company.
- Demonstrated knowledge, including application, of QSR/GMP (21 CFR Part 210, 211, 820) regulations, ISO/EU regulations/Standards (ISO 13485, EU MDR). Familiarity with other International Standards.
- Experience with an electronic Quality Management System software tool such as TrackWise, MasterControl, or equivalent is required.
- High attention to detail and accuracy.
- The ability to successfully balance and prioritize multiple ongoing projects and tasks.
This position plays a lead role in the electronic Document Management System. Interaction with various levels of management is possible.
Normal office environment. Travel could be up to 10%.