Documentation Control Intern

Job Description:

About Trans Medics

Trans Medics is transforming organ transplantation through the Organ Care System (OCS), an advanced medical technology platform. Operating within a highly regulated global environment, our Quality team ensures compliance with GMP, GDP, and international regulatory standards. Documentation control is critical to maintaining product safety, traceability, and regulatory readiness.

Position Summary

The Documentation Control Intern will gain hands-on experience in document management principles within a regulated medical device environment. This role supports the development, maintenance, and continuous improvement of document control processes to ensure compliance with global regulatory requirements.

This internship is ideal for students interested in Quality Systems, Regulatory Affairs, Operations, or process-driven environments.

KEY RESPONSIBILITIES:

Document Management Support

* Assist with processing and maintaining GMP and GDP documentation

* Support document routing, review, approval, and archival processes

* Ensure documents meet formatting, version control, and traceability requirements

* Maintain accurate records within document management systems

Compliance & Process Improvement

* Support adherence to global regulatory and quality system requirements

* Assist in identifying opportunities to improve document workflows

* Help maintain document tracking logs and status reports

* Participate in audits or audit preparation activities as needed

Operational & Administrative Support

* Assist with filing, scanning, and organizing controlled documents

* Support database updates and data entry tasks

* Manage multiple priorities in a fast-paced environment

* Lift and move document boxes or materials (up to 40 lbs) when required

What You'll Learn

* GMP (Good Manufacturing Practice) and GDP (Good Documentation Practice) principles

* The structure of quality systems in medical device companies

* Regulatory compliance fundamentals

* Document lifecycle management

* How traceability and accuracy protect product integrity

Qualifications

* High School Senior, College Freshman, Sophomore, or Junior

* Strong attention to detail and organizational skills

* Proficiency in Microsoft Office (Word, Excel, Outlook)

* Database experience preferred

* Ability to multi-task in a fast-paced environment

* Strong written and verbal communication skills

* Ability to lift up to 40 lbs

Why This Internship Stands Out

You will gain foundational experience in regulated documentation systems that are critical to medical device manufacturing and global compliance. This role provides strong exposure to Quality and Regulatory operations within a life-saving technology company.

Hours:

30-40 hours per week

Every Organ Wasted is a Life Not Saved.

Trans Medics, Inc. is a commercial-stage medical technology company transforming organ transplant therapy for patients worldwide. Our mission is to help save more patients' lives by increasing access to viable donor organs for those who are awaiting an organ transplant. To accomplish this mission, we partner closely with transplant stakeholders worldwide and help expand their access to healthy donor organs, while delivering the highest quality technology, service, clinical care and outcomes.

Driven by a passion for improving patient care, we make the impossible possible and keep our employees at the center of everything we do. Together, we strive to enhance the quality of life for transplant recipients and their families, fostering hope and healing in the journey toward better health.

Maximize your potential at Trans Medics, Inc.

Employee Benefit:

Medical with Health Reimbursement Account through Blue Cross/Blue Shield of MA

Dental

Vision

Healthcare Flexible Spending Account

Dependent Care Flexible Spending Account

Short Term Disability

Long Term Disability

401K Plan

Pet insurance

Employee Stock Purchase Plan

Trans Medics is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sex, national origin, marital status, age, disability or protected veteran status, or any other characteristic protected by law. We are committed to creating an inclusive environment for all employees.