Sr. Specialist, Document Control
About the positionResponsibilities• Performs initiation, issuance processing, routing, distribution, reconciliation and archiving of cGMP documentation on a non-routine basis. • Issues logbooks as requested from the EDMS. • Manages the periodic review program for site documents. • Creates and maintains templates for local documents and provides input for global documents. • Serves as point of contact for the EDMS across site and network. • Provides support for the resolution of complex issues related to the EDMS and other electronic documentation systems (e.g., electronic batch records, ValGenesis).• Performs gaps analysis to align local procedures with global procedures and policies. • Identifies improvement opportunities and drives the execution of site/team continuous improvement goals and projects. • Support internal and external inspections as required. • May present individual topics during audits as needed. • Maintain compliance with assigned learning plan. • Support development and delivery of training content to cross functional teams. • Support integration of newer team members and provide guidance and coaching to users of the EDMS, as required.• Lead meetings and represent function at cross functional and network meetings. • Share data/knowledge within and across site and network. • Build & maintain strong relationships with partner functions. • Act as Document Control SME to assist with completion of Quality Records as required including CAPAs, Deviations, and Change Controls. Requirements• Bachelor's degree in STEM field preferred. • High school diploma/Associates degree with equivalent combination of education and work experience may be considered.• 4+ years of experience in document control organization/function. • Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing is preferred. • Demonstrated experience with quality management systems. • Experience with EDMS is required. Benefits• Competitive benefits, services and programs that provide resources to pursue goals at work and in personal lives. Apply tot his job