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.