Quality Assurance Document Control Associate II

Responsibilities

• Maintain and administer the document control system for the Quality Management System (QMS).
• Ensure controlled documents are reviewed, approved, issued, and revised in accordance with established procedures.
• Manage document numbering, formatting, version control, and change history.
• Manage the lifecycle of SOPs, work instructions, forms, policies, specifications, and records.
• Issue product batch records and finished product labels.
• Provide document control support during internal, customer, and third-party audits.
• Coordinate training assignments when new or revised documents are released.
• Identify opportunities to improve document control processes and workflows.

Requirements

• Minimum of 2 years of experience in quality.
• 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.

Preferred Qualifications

• Experience working in an ISO 9001:2015-certified environment.
• Certification in ISO 9001:2015 auditing (e.g., Lead Auditor or Internal Auditor).

About the Company

Repligen is a global leader in bioprocessing, dedicated to inspiring advances in the production of biologic drugs that improve human health worldwide. We provide innovative technologies and solutions that help set new standards in bioprocessing, fostering a culture of purpose, collaboration, and shared success.