Documentation Specialist This position is for an entry-level Documentation Specialist who will be responsible for supporting the manufacturing of products by creating / processing / reviewing production batch records following established GDP / GMP processes and procedures. Summary :
- Reviews documents for format, accuracy and compliance with existing procedures, providing feedback on content as appropriate in collaboration with area experts.
- Coordinates with team members to efficiently process Change requests according to ISO / quality / change management standards.
- Follow procedures and work instructions to execute production tasks.
- Complete inventory and quality transaction 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).
- 0-2 years in a regulated industry (medical device, pharmaceutical, biotechnology preferred).
- Experience working with ERP systems such as SAP, and Product Lifecycle Management, preferred.
- May have general knowledge of Good Documentation Practices (GDP).
- Good oral and written communication skills.
- Proficient in Microsoft Office suite and Visio.
- Team player, flexible, and quality minded.
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