Documentation Specialist

Documentation Specialist II (ManufacturingQuality)- First Shift1 YearHybrid in Waltham, MAJob ResponsibilitiesDocument Control:• Run Daily Report - QualiPSO Veeva Documents• AcceptClosed DCR's• Assist with procedure assignment in curriculums (assist training coordinator)• Assist with paper document archiving and indexing• Assist with logbookMMRsBMRs management where needed - scanning, archiving, closing out request forms• Attend meetings as needed.• Assist with Document Vault• Assist with general DC supportQuality Systems:• Support and manage TPCN Change Controls (CC)• This role will require ensuring all CC details are populated accurately, launchingstarting 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 materialsservicesagreements are in place and accurate• General QS supportEducation & 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.

Created: 2024-11-09