Job Opening: Document Control Specialist

The Document Control Specialist is responsible for the lifecycle management of controlled documents to ensure accuracy, consistency, traceability, and compliance with company procedures and applicable regulatory standards. This role serves as a key support function within the Quality Management System (QMS) and works closely with Quality Assurance, Engineering, Manufacturing, Regulatory Affairs, and other cross-functional teams to ensure documentation is current, properly approved, and audit-ready at all times.

• Administer the creation, review, approval, revision, and obsolescence of controlled documents including SOPs, work instructions, forms, templates, specifications, and records.
• Ensure documents follow established formatting, numbering, naming, and version control standards.
  Maintain electronic documents, physical documents, and archives.
• Verify that only current, approved documents are available at points of use.
• Control distribution of documents and ensure acknowledgment or training requirements are met.
• Coordinate document change requests and ensure timely processing through approval workflows.
• Track document status, revision history, and effective dates.
• Ensure obsolete or superseded documents are removed from use and archived per retention requirements.
• Maintain traceability between related documents, records, and change controls.
• Ensure documentation complies with applicable regulatory and quality standards including ISO 9001, ISO 13485, FDA QSR, and GMP requirements.
• Support internal and external audits by retrieving documentation and preparing audit packages.

Experience in document control, quality assurance, quality systems, or regulated manufacturing environments preferred.
Knowledge of Quality Management Systems (QMS) and document control processes.
Familiarity with ISO 9001, ISO 13485, FDA QSR, GMP, or other regulated industry standards preferred.
Strong organizational skills with the ability to manage multiple priorities and deadlines.
Excellent attention to detail and accuracy.
Strong written and verbal communication skills.
Ability to read, analyze, and interpret technical procedures and government regulations.
Proficient in Microsoft Office Suite and electronic document management systems.
Ability to maintain confidentiality and handle sensitive information appropriately.
Ability to work independently and collaboratively in a team environment.
Strong problem-solving and critical-thinking skills.
Ability to support audits and maintain audit-ready documentation.
High school diploma or equivalent required; additional education or certifications in Quality, Regulatory Affairs, or related fields is a plus.

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