Documentation Specialist II - Integrated Resources, Inc

Waltham, MA 02451

About the Job

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

Source : Integrated Resources, Inc