Quality Assurance Document Control Associate II

RepliGen Corporation • Clifton Park, NY

3d • $23 - $29

About The Position

The Quality Assurance Document Control Associate is responsible for the administration, maintenance, and control of Quality Management System (QMS) documentation in accordance with the requirements of ISO 9001:2015. This role ensures that documented information is properly reviewed, approved, distributed, and maintained to support regulatory compliance, operational efficiency, and document integrity across the organization. The position supports document lifecycle management including creation, revision, archival, and retrieval of controlled documents such as Standard Operating Procedures (SOPs), work instructions, forms, policies, specifications, and records. This role is expected to model our Leadership Behaviors—Integrity & Compliance, Customer Focus, Collaboration, Courage, Team Empowerment, and Accountability & Results—in all aspects of work.

Requirements

• Minimum of 2 years of experience in quality, preferably in an ISO 9001:2015-certified environment.
• Strong knowledge of QMS principles, auditing, and process improvement methodologies.
• Proficiency in using quality management software and Microsoft Office Suite.
• Excellent communication, organizational, and analytical skills.

Nice To Haves

• Certification in ISO 9001:2015 auditing (e.g., Lead Auditor or Internal Auditor) is a plus.

Responsibilities

• Maintain and administer the document control system for the Quality Management System.
• Ensure controlled documents are reviewed, approved, issued, and revised in accordance with established procedures.
• Manage document numbering, formatting, version control, and change history.
• Ensure obsolete documents are promptly removed from use and archived appropriately.
• Maintain document retention and archival processes in accordance with company policies.
• Issue product batch records and finished product labels.
• Coordinate the creation and revision of SOPs, forms, policies, and quality records.
• Ensure documentation meets internal standards for formatting, clarity, and compliance.
• Maintain the master list or document register for all controlled documents.
• Support cross-functional teams with document updates and change requests.
• Ensure documented information complies with QMS requirements and applicable regulatory standards.
• Provide document control support during internal, customer, and third-party audits.
• Retrieve and provide documentation and records requested during audits or inspections.
• Assist with periodic reviews of QMS documentation to ensure accuracy and effectiveness.
• Distribute controlled documents to appropriate personnel and departments.
• Coordinate training assignments when new or revised documents are released.
• Ensure employees have access to current versions of required documentation.
• Identify opportunities to improve document control processes and workflows.
• Participate in quality improvement initiatives and QMS projects.

Benefits

• paid time off
• health/dental/vision
• retirement benefits
• flexible spending accounts

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: No Education Listed