Documentation Control Intern

TransMedicsAndover, MA
3h

About The Position

About TransMedics TransMedics 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.

Requirements

  • High School Senior, College Freshman, Sophomore, or Junior
  • Strong attention to detail and organizational skills
  • Proficiency in Microsoft Office (Word, Excel, Outlook)
  • Ability to multi-task in a fast-paced environment
  • Strong written and verbal communication skills
  • Ability to lift up to 40 lbs

Nice To Haves

  • Database experience preferred

Responsibilities

  • 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
  • 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
  • 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

Benefits

  • 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
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