Documentation Specialist

3 weeks ago


Waltham, United States Randstad Life Sciences US Full time

Documentation Specialist II (Manufacturing/Quality)- First Shift

1 Year

Hybrid in Waltham, MA


Job Responsibilities

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 • 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

Education & Qualifications

• Min HS diploma but 5-7 years experience.

• Must have experience with Veeva and experience supporting and managing TPCN 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.



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