Quality Assurance Document Control Associate II

Make a global impact-join Repligen.

We're united by a mission to inspire advances in bioprocessing as a preferred partner in the production of biologic drugs that improve human health worldwide. No matter your role or background, at Repligen, you will play a key part in shaping some of the most innovative and life-changing therapies in the world. We foster a culture of purpose, collaboration, and shared success-where every voice matters and every contribution drives progress. Join us!

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.

Key Responsibilities:

Document Control Management

• 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.

QMS Documentation Support

• 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.

Compliance and Audit Support

• 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.

Training and Distribution

• 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.

Continual Improvement

• Identify opportunities to improve document control processes and workflows.
• Participate in quality improvement initiatives and QMS projects.

Qualifications:

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

Our mission is to inspire advances in bioprocessing as a trusted partner in the production of biologic drugs that improve human health worldwide. Focused on cost and process efficiencies, we deliver innovative technologies and solutions that help set new standards in bioprocessing. The estimated hourly rate for this role, based in the United States of America is $22.53 - 29.00. Compensation decisions are dependent on several factors including, but not limited to an individual's qualifications, location, internal equity, and alignment with market data. Additionally, employees are eligible to participate in one of our variable cash programs (bonus or commission) and eligible roles may receive equity as part of the compensation package. We offer a wide range of benefits such as paid time off, health/dental/vision, retirement benefits and flexible spending accounts. All compensation and benefits information will be confirmed in writing at the time of offer.