Documentation Specialist II

Job title: Documentation Specialist II
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

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