Overview

Posted
1 week, 6 days ago
Internship Type
Spring
Remote Status
Hybrid
Location
Durham, NC, US
Education Level
Bachelor
Education Status
Undergraduate Student
Field of Study
Not specified
Categories
Quality Management
Skills
Data Archiving Metadata Review Quality Checks ALCOA++ GxP Compliance
Tags
Not specified
We are looking for an intern who can start work in March with an anticipated length of around 5-6 months.

The Quality Assurance Intern (Archive) will support the Quality Assurance team by helping organize, transfer, and maintain electronic and paper laboratory records. This role provides hands-on experience working with laboratory data, learning how information is securely stored, tracked, and protected in a regulated environment. The intern will assist with data archiving, metadata review, and basic quality checks while working closely with the Archivist and QA team to ensure records are accurate, complete, and inspection-ready.

Essential Responsibilities

  • Assist in the transfer of raw electronic data directly from laboratory equipment into secure, validated systems and/or the electronic archive.
  • Ensure that archived files are accompanied by critical metadata, such as analysts IDs, time and date stamps, and instrument ID numbers.
  • Apply ALCOA++ standards to verify that archived data is Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available, and Traceable. 
  • Maintain stringent access control procedures to prevent unauthorized access or modification of electronic records as required by FDA regulations.
  • Assist in applying specific record retention schedules defined by GxP regulations for different types of study data.

    • Additional Responsibilities

  • May assist in generating certified copies of archived materials
  • Assist the archivist or assistant archivist with hard-copy paper archival
  • Other duties as assigned

    • Minimum Acceptable Qualifications: Education/Experience

  • Currently enrolled as a rising junior or senior in a four-year college or university
  • Intermediate computer skills/knowledge

    • Minimum Acceptable Qualifications: Skills

  • Must work effectively within team to meet objectives
  • Ability to take direction well and multi-task
  • Detail oriented and organized
  • Proficient computer skills 

    • Working Environment

  • Primarily office environment, with occasional opportunities for remote work
  • Routinely uses standard office equipment such as computers, phones, photocopiers, and filing cabinets

    • Position Type and Expected Hours of Work

  • This is a six-month temporary position that requires a minimum of three-four business days onsite