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
