QA Document Control Specialist II

About the role

This position assists in technical documentation management regarding instructional documents in compliance with regulations, Good Manufacturing Practices (GMPs) and Good Documentation Practices (GDPs).

Responsibilities

• Any DC Specialist I responsibility
• Manage technical writing of standard operating procedures and other supporting instructional documents and forms
• Facilitate inter-departmental document collaborations
• Attend inter-departmental meetings as QA representative
• Train other document users in instructional documentation practices
• Support regulatory audits as assigned
• May be required to work annual company convention
• Performs other duties as assigned by QA Management

Requirements

• High School Diploma or equivalent; Associate degree preferred
• Document Control experience in a regulated environment
• Technical writing and editing proficiency
• Must be detail oriented, self-motivated, and collaborative
• Experience with Microsoft Suite, Quality Management Systems, Electronic Resources Planning Systems, Project Management Systems
• Experience with manufacturing regulations (CFR, NHP, TGA, ISO, etc.)
• Must be willing and able to spend most of the workday performing computer-based tasks