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).
* Good oral and written communication skills.
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