Job title:- Documentation Specialist

Location:- Waltham, MA 02451 (Full Onsite)

Duration:- 12 Months

Pay Rate Range: $40.00- $44.00/hr on W2

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.

Description:

• 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

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