Senior Documentation Coordinator

At Mentor Technical Group, a world leader in life science engineering and technical solutions, we are seeking a highly skilled Senior Documentation Coordinator to join our team. This role is perfect for an individual who is passionate about ensuring compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines.

Job Summary:

• We offer a competitive salary of $65,000 - $90,000 per year, depending on experience.
• This position is responsible for driving and facilitating the timely change, approval, and release of documentation according to project schedules.
• The ideal candidate will have 3+ years of experience with various aspects of document control, including creating, reviewing, formatting, preparing, and routing GMP documents in a documentation control system.
• We are an equal opportunity employer and welcome applicants from diverse backgrounds.

About Us:

Mentor Technical Group provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. With offices in multiple locations, we serve life sciences clients globally. Our team is dedicated to ensuring that our clients receive high-quality services and products.

Responsibilities:

1. Perform all aspects of complex engineering changes, including ECO/Change Action (CA) processing, parts lists (BOM's) changes, ERP input, manufacturing processes, and general document verification.
2. Monitor configuration and documents changes management process effectiveness, including the impact of changes, and take the initiative to recommend configuration and change management process improvements.
3. Assist in the implementation and maintenance of documentation and configuration assurance processes for the control of review, revision, distribution, production, retrieval of records associated with device master records, design history records, and other quality records using document management applications.
4. Facilitate the timely release and changes of documentation with documentation authors and approvers according to project schedules.
5. Evaluate and analyze policies, procedures, and trend data to identify quality records required by development and manufacturing according to internal policies and Regulatory requirements.

Requirements:

• Bachelor's degree completed.
• 3+ years of experience with various aspects of document control, including creating, reviewing, formatting, preparing, and routing GMP documents in a documentation control system.
• Previous experience within the regulated industry is highly preferred.

Benefits:

Mentor Technical Group offers a range of benefits, including a competitive salary, comprehensive health insurance, retirement plan, and opportunities for professional growth and development.