Document Control Assistant(Looking to Fill Quickly)
MillenniumSoft Inc · Tempe, AZ · 2 mo ago
AccountingFull-time
About the role
This is a 12-month contract position located in Tempe, AZ, with a 40-hour work week on the 1st shift. The role requires participation as an active team member to ensure compliance with regulations, internal and external policies, and procedures. Responsibilities include processing requested changes and maintaining controlled documentation and supporting systems.
Responsibilities
- Review and analyze proposed changes to controlled documentation.
- Ensure documentation meets all division, corporate, and department requirements.
- Perform training in change control procedures and other department functions; may cross-train in other department functions.
- Implement documentation and change control using electronic documentation and change control software.
- Cross-train on additional software including JD Edwards, Master Control, Microsoft Word, Access, Excel, Harrington, Microsoft Teams, and One Drive.
- Participate in FDA, Corporate, and internal audits.
- Perform data analysis and run system reports.
- Process requested changes and maintain controlled documentation and supporting systems.
- Update procedures using Word/Excel, ensure correct formatting, and verify internal and external references (SOPs, work instructions, create links, assign approvers, etc.).
- Follow checklists, verbal, and written direction; verify data entry fields for accuracy.
- Work on straightforward tasks using established procedures; work is subject to review by others.
Requirements
- Good attention to detail is a must.
- Ability to work in a team environment and communicate clearly and effectively.
- Ability to multi-task and prioritize workload.
- Positive and professional attitude.
- Experience in a documentation-related position, preferably in an FDA and/or regulated environment.
- Experience with Electronic Document Management Systems; Master Control experience is preferred.
- Medical Device Industry experience is a plus.
- Experience in a regulated environment (e.g., FDA, ISO) is preferred.
- Minimum of an Associate’s Degree; Bachelor's degree is highly preferred.