Quality Assurance Document Control Associate II

Key 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.

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.
• Afford assistance with periodic reviews of QMS documentation to ensure accuracy and effectiveness.

Distribution and Training

• Distribute controlled documents to appropriate personnel and departments.
• Cook up 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.

Pay

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.

Schedule

Not specified.