Quality Assurance Specialist - Document Control

Regulatory Jobs; Rockaway (NJ); On-site; USD 65,000 - 90,000; Full time

Job summary

Regulatory Jobs is seeking a detail-oriented Document Control Specialist to implement and adhere to control procedures for medical device documentation in New Jersey. You will format and edit documents related to product development, quality assurance, and manufacturing processes.

You will coordinate reviews, assist with DCRs, and support training deployment while maintaining training records. A Bachelor’s degree with 2–5 years of related experience and GAS knowledge are preferred.

Qualifications

• Bachelor’s degree or equivalent practical experience in a medical device setting.
• Knowledge of US FDA Quality System Regulations (QSR).
• Self-starter with ability to manage multiple projects simultaneously.
• Proficient in MS Excel and MS Word.

Responsibilities

• Assist with initiating and executing Document Change Requests (DCR) and maintain Document Master files.
• Draft and review policies, procedures, work instructions, and related controlled documents.
• Coordinate training plans and records for new hires and existing staff.
• Ensure timely communication with departments to disseminate documentation needs and support QA/Regulatory activities.

Skills

Document control

Version control

MS Excel

MS Word

Multi-project management

Education

Bachelor’s degree

Equivalent combination of education and experience

Tools

Grand Avenue GAS

Job description

Description

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.