What are the responsibilities and job description for the Documentation specialist position at Aequor Technologies LLC?
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 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 :
1. Support and manage TPCN Change Controls (CC)
a. 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.
2. Support and manage Third Party (TP) Quality Events
a. Track all significant TP events, manage reoccurring meetings, work with owners and quality reps
3. Third Party (TP) Management
a. Conduct TP Initial Risk Assessments and ensure SMEs perform annual performance assessments
4. Veeva QTP Support
a. Ensure all associated TP Entities are active in the database and all materials / services / agreements are in place and accurate
5. General QS support
Last updated : 2024-11-26
