Quality Assurance Document Control Associate II

The Quality Assurance Document Control Associate is responsible for the administration, maintenance, and control of Quality Management System (QMS) documentation in accordance with ISO 9001:2015. The role ensures documented information is properly reviewed, approved, distributed, and maintained to support regulatory compliance, operational efficiency, and document integrity across the organization. Key Responsibilities Document Control Management: Maintain and administer the document control system for the QMS. 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 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. Compensation: 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. Employees are eligible to participate in a variable cash program (bonus or commission) and may receive equity as part of the compensation package. Benefits include paid time off, health/dental/vision coverage, retirement benefits, and flexible spending accounts. #J-18808-Ljbffr Repligen Corp