The Documentation Specialist who will be responsible for supporting the manufacturing of products by creating, processing and reviewing production batch records. The Doc Specialist will follow established GDP & GMP processes and procedures.
Summary:
Review documents for format, accuracy and compliance with existing procedures; provide feedback on content as appropriate in collaboration with area experts
Coordinate with team members to efficiently process Change requests according to ISO, quality and/or change management standards
Follow procedures and work instructions to execute production tasks
Complete inventory and quality transactions in SAP Inventory System
Complete required documentation in an accurate and timely manner following Good Documentation Practices (GDP).
Requirements:
Associate degree or equivalent (science field preferred).
Experience in a regulated industry is preferred; ideally med device, pharma or biotech
Experience working with ERP systems such as SAP, and Product Lifecycle Management, preferred.
General knowledge of Good Documentation Practices (GDP).