Job Details

Documentation Specialist

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.
• Proficient in Microsoft Office suite

Pay Rate: $24 - $27 per hour