Document Control Specialist - Compunnel : Job Details

Job Title: Document Control Specialist

Location: Oneonta, NY 13820

Schedule: Monday-Friday, 8:00 AM – 5:00 PM (100% Onsite)

Job Description:

The Document Control Specialist is responsible for managing and maintaining the quality management system (QMS) documentation and records in compliance with ISO standards. The role supports ongoing projects to improve documentation systems and prepare for audits. This includes creating, revising, and organizing quality system documents such as procedures, work instructions, and certificates of conformance.

Key Responsibilities:

• Generate, review, and maintain QMS documentation (e.g., procedures, work instructions, job aids) per ISO 13485, ISO 9001, and 21 CFR 820 standards.
• Initiate and manage Change Controls and Document Change Requests.
• Collaborate with departments to update and improve processes and procedures.
• Organize and manage document review and retention processes.
• Support or lead continuous improvement initiatives for document control processes.
• Assist with quality assurance activities, including internal audits and corrective action/preventive action (CAPA) processes.
• Other tasks as assigned.

Education: Associate or Bachelor's degree.

Experience: Minimum 2 years of relevant experience (preferably in a manufacturing environment).

• Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint).
• Experience with ETQ or similar Document Management software (preferred).
• Knowledge of ISO 9001, ISO 13485, and 21 CFR 820 Quality Management Systems (highly preferred).

Skills:

• Strong organizational skills with attention to detail and accuracy.
• Ability to manage multiple resources and tasks effectively.
• Comfortable working independently and collaboratively.
• Excellent communication skills (written and verbal).

Preferred Skills:

• Prior experience in a manufacturing or regulated industry environment.
• Familiarity with document control and quality system standards in the life sciences or similar industries.

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