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