Quality Assurance Specialist - Document Control

electroCore Inc • Rockaway, NJ

1d

About The Position

This role involves implementing and adhering to document control procedures, including version control, document approval, and archiving. The specialist will create and edit documentation related to product development, quality assurance, and manufacturing processes. They will coordinate reviews and approvals for new or revised documents, assist in the development and implementation of Document Change Requests, and help deploy training materials while maintaining training records. Other quality-related functions may also be assigned.

Requirements

• 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.
• 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.

Nice To Haves

• Knowledge of Grand Avenue Software (GAS) preferred.

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.
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level