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USA Documentation Specialist II

1 month ago

Waltham, Massachusetts, United States eTeam Full time

Job Description:

As a Documentation Control Specialist at eTeam, you will be responsible for supporting the Doc Control and Quality Systems departments. Your key responsibilities will include:

Document Control:

* Run Daily Reports using QualiPSO Veeva to ensure documents are accepted and closed.
* Assist with procedure assignment in curriculums and help with paper document archiving and indexing.
* Manage logbooks, MMRs, and BMRs, including scanning, archiving, and closing out request forms.

Quality Systems:

* Support and manage Third Party (TP) Change Controls (CC), ensuring all details are populated accurately.
* Launch and start CC, assign a change plan owner, and work with SMEs to conduct impact assessments.
* Track significant TP events, manage recurring meetings, and work with owners and quality reps.

TP Management:

* Conduct TP Initial Risk Assessments and ensure SMEs perform annual performance assessments.

Veeva QTP Support:

* Ensure all associated TP entities are active in the database and materials/services/agreements are accurate.

General QS Support:

* Provide support to the QS department as needed.