Documentation Specialist II
4 weeks ago
Job Location: Waltham, MA
Job Duration: 12+ months
Pay Range : $42/hr. on W2
Job Description: Onsite Role
This candidate will support Doc Control and Quality Systems departments. Required to be onsite for support as needed.
Perform the following activities:
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
Quality Systems:
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.
- Support and manage Third Party (TP) Quality Events
- Track all significant TP events, manage reoccurring meetings, work with owners and quality reps
- Third Party (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 all materials/services/agreements are in place and accurate
- General QS support
#sczr2
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