Document Control Access Specialist

RXinsider LTD.; Plymouth, Northern (MN, KY); Hybrid; USD 25,000 - 49,000; Full time

Job summary

Abbott is seeking a Quality Access Management specialist to support access control for a document management system within the Electrophysiology business. The role requires reviewing requests, granting and adjusting user access, and supporting audits and inspections while maintaining accurate records.

You'll work in a highly matrixed environment, communicating across levels and ensuring compliance with FDA, GMP, and ISO 13485 standards.

Qualifications

• High School Diploma or GED required.
• 1–3 years’ experience in documentation control or product surveillance systems preferred (Windchill).
• Knowledge of FDA, GMP, and ISO 13485.
• Strong written and verbal communication skills.
• Medical device experience preferred.
• Ability to work in a matrixed, fast-paced environment.
• Ability to work independently and as part of a team.
• Attention to detail and strong follow-up skills.

Responsibilities

• Process documentation system access requests and ensure timely completion per procedures.
• Review access requests for completeness, accuracy, approvals, and compliance.
• Grant, modify, and remove user access within documentation and quality systems.
• Provide user support and guidance on access-related inquiries.
• Troubleshoot and resolve access issues and incidents.
• Maintain records of access management activities.
• Support audits, inspections, and periodic access reviews.
• Drive process improvements to enhance efficiency and service.
• Collaborate with cross-functional stakeholders to ensure compliant access management.

Skills

Verbal and written communications

Multitasking

Organizational skills

Teamwork

Report writing

Education

High School Diploma/GED

Tools

Windchill

Job description

Abbott is seeking a Quality Access Management specialist to support access control for a document management system within the Electrophysiology business. The role requires reviewing requests, granting and adjusting user access, and supporting audits and inspections while maintaining accurate records.

You'll work in a highly matrixed environment, communicating across levels and ensuring compliance with FDA, GMP, and ISO 13485 standards.