Change Control Associate

Job description

Essential Duties and Responsibilities: - Prepare technical Quality documents including but not limited to batch records for new products and products requiring changes through creation, review, and approval to ensure compliance prior to final release for production. - Understand and comply with all standard operating procedures applying to the change control process. - Contribute to ongoing process improvements with focus on document accuracy, efficiency, and regulatory risk mitigation. - Collaborate cross-functionally with Product Managers, Research & Development (R&D), Procurement, Quality Control (QC), Regulatory, and others to gather information and provide feedback related to change control product documentation. - Create and update relevant information within electronic Quality Management Systems (QMS). - Manage workflow of documents and communicate with colleagues to track documents to release. - Monitor production schedule and prioritize workload based on production scheduling changes. - Understand and follow Good Documentation Practices (GDP) requirements with a focus on Change Control. - Audit new or changed documents for accuracy. - Provide backup support as directed, in...