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Duties/Responsibilities |
1 |
Responsible for administration of the electronic document management system (Master Control) ensuring seamless operation, maintenance, and user support |
2 |
Develop and maintain installation and configuration management procedures. |
3 |
Execute daily user administration tasks including creating, modifying, and disabling user accounts per approved procedures |
4 |
Work closely with software provider to resolve system issues, propose enhancements, troubleshoot and resolve application issues, and test and implement additional functionality within the system |
5 |
Proactively follow up on Master Control support issues to provide updates and resolutions to end users. |
6 |
Coordinate and communicate with impacted stakeholders as needed. |
7 |
Collaborate with cross-functional teams to ensure quality standards are met throughout the product lifecycle |
8 |
Investigate deviations within the Master Control system and develop comprehensive correction action plans |
9 |
Conduct final Quality review of GMP documentation within Master Control workflow |
10 |
Perform essential day to day administrative hands-on tasks |
11 |
Coordinate with process owners to deploy new modules, including developing and delivering training to process owners and users |
12 |
Monitor and report on key quality metrics, identifying trends and areas for improvement; includes developing reports to enable efficient real time reporting |
13 |
Support regulatory, organizational, and vendor audits as needed |
14 |
Write and revise SOPs as necessary to ensure compliance, efficiency and clarity |
15 |
Participate in quality and process improvement initiatives as well as project teams |
16 |
Ability to work with minimal instructions on routine work and detailed instructions on new assignments |
17 |
Other duties as assigned |