Documentation Coordinator

Published on: Jun 4, 2025

Country: United States

Location: Northbrook, Illinois

Company: Luminex Corporation

Job Category: Operations

Employment type: Regular Full Time

Req ID: 7030

Diasorin is a global leader in diagnostic solutions, pushing the boundaries of science and technology to create cutting-edge tools that improve healthcare worldwide. With a legacy spanning over 50 years, we've earned our reputation for excellence by developing innovative diagnostic assays and instruments that are trusted by healthcare providers around the world.

Our broad offering of diagnostic tests and Licensed Technology solutions, made available thanks to ongoing investments in research, positions us as the player with the widest range of specialty solutions in the sector and identifies us as the "Diagnostics Specialist."

Why Join Diasorin?

Impactful Work: When you join Diasorin, you become part of a team that's dedicated to improving lives. Your contributions will directly impact patient care, making a meaningful difference in the world.

Global Reach & Innovation: Our work transcends borders. Joining Diasorin means collaborating with colleagues from all over the world, expanding your horizons, and contributing to global healthcare solutions at the forefront of the diagnostic industry.

Diverse and Inclusive Culture: We believe in the strength of diversity, and our inclusive culture reflects this commitment. We value your unique perspective and offer a supportive, collaborative environment where everyone can thrive.

Join Our Team: If you're passionate about innovation, diversity, and making a positive impact on healthcare, Diasorin is the place for you. We're looking for passionate and talented individuals who are ready to embrace new challenges and drive healthcare solutions forward.

Are you ready to be part of a dynamic team that's shaping the future of diagnostics? Join Diasorin and become a catalyst for change in the world of healthcare. Apply today and be a part of our exciting journey toward a healthier, more connected world. Together, we can make an impact!

Job Scope

The Documentation Coordinator will manage the primary issue of document numbers, part numbers, project numbers, archival and retrieval, maintaining files and databases of all controlled and other quality-relevant documents of the company including lab notebooks, audit reports, SOPs, training records, design history record, all procedures and work instructions and all released product information. This role will perform other tasks related to on-going QA programs.

Duties and Responsibilities

Issue document numbers, part numbers and project numbers

Process all document and drawing changes including preparation, formatting, distribution, routing, maintenance and release to authorized users

Process and maintain the manual/electronic routing, tracking, distribution and retrieval of documents

Create and maintain bills of material using Agile

Perform document control activities, including assembling batch records, assigning tracking numbers, record filing, and lab notebook issuances.

Maintain document filing system and electronic databases for archived regulatory information. Retrieve stored information upon request.

Assist with employee training and development of QA training materials.

Assist with internal audits and assist with vendor/supplier audits.

Assist in development of documentation (batch records, documentation supporting submissions)

May write and/or implement changes to controlled documents (e.g., SOPs, Specifications, Methods, etc.) as needed.

Independently understand, follow and implement instructions, including the ability to help others understand and implement these instructions

Prioritize projects appropriately and with flexibility to accommodate changing company objectives

Other duties as assigned.

Education, Experience, and Qualifications

Associate's Degree
Documentation, archiving and records management (experience in regulated industry/medical device industry highly desirable).
Experience as an Agile power user
Working knowledge of Agile database usage and change control process
Computer proficient in PC based software such as Excel, MS Word, Access, Power Point, Portable Document Format (pdf) and Adobe Acrobat Writer/Distiller
Knowledge of ISO 9001:2000, ISO 13485:2003 and FDA QSRs
Knowledge of internal auditing and supplier qualification and auditing is preferred.
Experience with Agile or MasterControl Electronic Data Management Systems is preferred.

Travel Requirements

10% Travel may be required

What We Offer
Salary Range
The hourly range for this position is $16.68 - $26.69. The salary range for this role represents the numerous factors considered in the hiring decisionsincluding, but not limited to, educations, skills, work experience, certifications, etc. Beyond base wages, Diasorin offers a competitive rewards packagefocused on your overall well-being. We are proud to offer a comprehensive plan of health benefits, retirement and financial wellbeing, time off programs,wellbeing support and perks. Benefits may vary by role, country, region, union status, and other employment status factors. You may also be eligible toparticipate in an annual incentive program. An incentive award, if any, depends on various factors, including, individual and organizational performance.

Diasorin is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status, and will not be discriminated against on the basis of disability.

In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and Canada and to complete the required employment eligibility verification document form upon hire.

Diasorin is committed to providing reasonable accommodations for qualified individuals with disabilities. If you are a US or Canada candidate and require assistance or accommodation during the application process, please contact the North America Talent Acquisition Team at hrtalent@diasorin.com or 1-800-328-1482 to request an accommodation.

The above job description is intended to describe the general content, identify the essential functions, and set forth the requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities, or requirements.

Diasorin reserves the right to modify or amend this job posting as needed to comply with local laws and regulations.

Please note that offers of employment at Diasorin may be contingent upon successful completion of a pre-employment background check and drug screen, subject to applicable laws and regulations.

This position is not eligible for partnership with a third-party search firm vendor without expressed, written consent from the Diasorin Human Resources Department.