USA-Documentation Specialist II
2 months ago
Location: Waltham, MA 02451 (Remote Role)
Duration: 12 Months
Job description:-
- HS diploma but 5-7 years' experience.
- Must have experience with Veeva and experience supporting and managing TPCN - (Third party tracking notification) & Change Controls (CC)
- Experience tracking all significant TP events, manage reoccurring meetings, work with owners and quality reps.
- Conduct TP Initial Risk Assessments and ensure SMEs perform annual performance assessments.
- This candidate will support Doc Control and Quality Systems departments. Required to be onsite for support as needed.
Document Control:
- Run Daily Report - QualiPSO Veeva Documents
- Accept/Closed DCR's
- Assist with procedure assignment in curriculums (assist training coordinator)
- Assist with paper document archiving and indexing
- Assist with logbook/MMRs/BMRs management where needed - scanning, archiving, closing out request forms
- Attend meetings as needed.
- Assist with Document Vault
- Assist with general DC support
Support and manage TPCN Change Controls (CC)
- This role will require ensuring all CC details are populated accurately, launching/starting the CC, assigning a change plan owner and working with change plan owner with SME Impact assessments and more.
- Track all significant TP events, manage reoccurring meetings, work with owners and quality reps
a. 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 all materials/services/agreements are in place and accurate
General QS support
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