Sr. Specialist, Document Control
About the position Responsibilities • 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