QA Document Control Specialist

Job description:

• Manage the end-to-end document control process, including document creation, review, approval, distribution, and archival, in accordance with regulatory requirements and company policies.
• Maintain the document management system, ensuring accurate documentation of all controlled documents and records.
• Collaborate with cross-functional teams to establish and maintain document control procedures, standards, and templates.
• Perform document reviews for accuracy, completeness, and compliance with regulatory standards, such as ISO 13485 and FDA regulations.
• Coordinate document change control processes, including initiating change requests, routing documents for review and approval, and ensuring timely implementation of approved changes.
• Conduct periodic audits of the document management system to ensure compliance with regulatory requirements and identify areas for improvement.
• Provide employees with training and support on document control procedures, including proper document handling, revision control, and electronic signature processes.
• Serve as a subject matter expert on document control-related matters during internal and external audits and inspections.
• Continuously monitor industry trends and regulatory updates related to document management and quality systems, and implement necessary changes to ensure compliance.
• Contribute to developing and implementing quality improvement initiatives aimed at enhancing document control processes and overall efficiency.

Qualifications:

• English level: Professional Working Proficiency
• Bachelor's degree in a relevant field such as engineering, life sciences, or business administration.
• Minimum of two years of experience in document control, preferably in the medical device or pharmaceutical industry.
• Knowledge of regulatory requirements and standards governing document control, including ISO 13485 and FDA regulations (e.g., 21 CFR Part 820).
• Proficiency in MS Office applications.
• Strong attention to detail, organizational skills, and ability to manage multiple tasks simultaneously in a fast-paced environment.
• Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.
• Demonstrated problem-solving skills and ability to work independently with minimal supervision.

Job Types: Full-time, Contract

Pay: $22.00 - $26.00 per hour

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift

Work Location: In person