Coordinator I Document Control

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 a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries.

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You’ll also have access to :

• Career development with an international company where you can grow the career you dream of.
• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with a high employer contribution
• Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
• A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.

In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives.

The Opportunity

This position is responsible for providing Quality support for access management of a document control system.

What You’ll Work On

• Process documentation system access requests and ensures timely completion in accordance with established procedures.
• Review requests for completeness, accuracy, approvals, and compliance requirements.
• Grant, modify, and remove user access within documentation and quality management systems.
• Provide customer support and guidance regarding access-related inquiries and requests.
• Troubleshoot and resolve documentation system access issues and incidents.
• Maintain accurate records and documentation of access management activities.
• Support audits, inspections, and periodic access reviews.
• Drive continuous improvement initiatives to enhance process efficiency and customer service.
• Collaborate with cross-functional stakeholders to ensure compliant and effective access management processes.

Required Qualifications

• High School Diploma/GED.
• 1-3 years’ experience. Prior experience with documentation control or product surveillance systems preferred, e.g. Windchill.
• Knowledge of FDA, GMP, and ISO 13485.
• Solid computer skills and report writing skills.
• Prior medical device experience preferred.
• Ability to work in a highly matrixed and geographically diverse business environment.
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
• Ability to leverage and/or engage others to accomplish projects.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
• Multitasks, prioritizes and meets deadlines in timely manner.
• Strong organizational and follow-up skills, as well as attention to detail.
• Ability to maintain regular and predictable attendance.

Preferred Qualifications

• Prior experience with documentation control systems, e.g. Windchill preferred.

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives : www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott, and on X @AbbottNews.

The base pay for this position is $17.85 – $35.75 per hour. In specific locations, the pay range may vary from the range posted.