QA Documentation Specialist - Remote

Overview

The QA Documentation Specialist will manage, review, and maintain quality system documentation and supporting documentation in compliance with regulatory standards and organizational policies.

In Short

• Full-time position in Research & Development.
• Remote work available for US residents.
• Focus on quality system documentation management.
• Experience with regulatory standards required.
• Hands-on experience with MasterControl preferred.
• Collaborate with cross-functional teams.
• Ensure compliance with FDA, EMA, and ICH regulations.
• Support internal and external audits.
• Assist in continuous improvement initiatives.
• Competitive salary and benefits package offered.

Requirements

• Bachelor’s degree in Life Sciences or related field.
• Minimum of 4 years in quality assurance or compliance.
• Experience with electronic document management systems.
• Strong knowledge of regulatory requirements.
• Excellent organizational and communication skills.
• Ability to manage multiple priorities.

Benefits

• Medical, Dental, Vision insurance.
• Flexible Spending Accounts.
• Employer paid Life and Disability insurance.
• 11 paid holidays with winter break.
• 401(k) employer match.