Quality Assurance Specialist - Document Control

Summary of Position

• Implement and adhere to document control procedures, including version control, document approval, and archiving
• Create and Edit Documents: Prepare, format, and edit documentation related to product development, quality assurance, and manufacturing processes.
• Coordinate Reviews: Facilitate the review and approval process for new or revised documents by coordinating with relevant departments or stakeholders
• Assisting in the development and implementation of the Document Change Requests for the company’s-controlled documentation.
• Assisting with the deployment of training materials to the company's employees and maintaining resulting training records.
• Other Quality related functions that may be assigned

Primary Job Responsibilities

• Assist with the initiation and execution of Document Change Requests for the release of new or revised Controlled Documents with respective departmental personnel; maintain DCR and Document Master and Locations specific files in accordance with established policies and procedures.
• Assist in drafting and reviewing new and revised documents, including but not limited to, policies, procedures, Work Instructions, and related Controlled Documents.
• Assist with the scheduling and execution of employee training with respective department / function management by reviewing and maintaining training plans and records for new hires and current employees.
• Communicate with various departments to gather and disseminate information related to documentation needs.
• Support Teams: Provide support to Quality Assurance, Regulatory Affairs, Engineering and Production teams by ensuring that they have access to the necessary documentation
• Other duties as may be assigned by manager.

Requirements

Qualifications

• Bachelor’s degree (B.A.) from four-year college or university; or two to five years related experience and/or training in medical device manufacturing; or equivalent combination of education and experience.
• Knowledge of Grand Avenue Software (GAS) preferred)
• Possess working knowledge of US FDA Quality System Regulations.
• Self-starter capable of managing multiple projects at one time
• Good working computer skills; knowledge of MS Excel and Word.