Intern-GCP, GLP Quality Assurance

Position Summary

The Quality Assurance Intern will support the QA team in activities related to Good Documentation Practices (GDocP), equipment validation, and Document Control Management within a biopharmaceutical laboratory environment. Based at Discovery 1 in Morrisville, North Carolina, this role provides hands-on exposure to GCP/GLP/GCLP regulations and how they apply to documentation systems, quality procedures, and regulated record-keeping practices. The intern will report directly to the Quality Assurance Manager (GCP/GLP) and will gain a strong foundation in Quality Assurance principles through daily interactions with the QA team.

This internship is located in RTP, NC and will report to the Quality Assurance Manager, GCP/GLP.

Job Responsibilities

• Learn what regulations apply to clinical and preclinical regulated research
• Learn and apply Good Documentation Practices (GDocP) across QA-related tasks and controlled documents
• Assist in maintaining, organizing, and reviewing controlled documents in accordance with established Document Control Management processes
• Support QA staff in verifying documentation accuracy, completeness, and compliance with GCP/GLP requirements
• Participate in routine document tracking, archival activities, and revision control workflows
• Gain familiarity with the regulations that apply to clinical and preclinical regulated research
• Gain a practical understanding of GDocP and how these practices support data integrity and regulatory compliance in biopharmaceutical research
• Develop foundational knowledge of Document Control Management principles, workflows, and systems used in GCP/GLP environments
• Build familiarity with QA processes and quality systems that govern regulated laboratory and clinical operations
• Strengthening attention to detail, critical thinking, and documentation skills is essential for quality-focused roles
• By supporting core documentation and quality processes, the intern will help ensure that records generated at Discovery 1 meet regulatory and organizational standards. Their contributions will enhance data integrity, support inspection readiness, and enable consistent compliance across GCP/GLP activities.

Minimum Requirements

• Must be pursuing a BA/BS degree in Medical Research or Science, Biology, Chemistry, Pharmacy, Biotechnology, Bio/Pharmaceutical Engineering
• Must be at least a junior in university at time of the application
• Strong sense of accountability and ability to prioritize multiple tasks
• Excellent organizational skills and attention to detail
• Flexible and willing to support a variety of tasks for the QA team
• Available to work full-time at the office during the summer months (May-August)

Preferred Education, Experience and Skills

• Prior internship, work, or volunteer/extracurricular experience
• Prior experience working in a lab environment

AskBio Inc. (AskBio) is an Equal Opportunity Employer and does not discriminate against any employee or applicant for employment because of race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status or any other protected status prohibited under Federal, State or local laws. All employment decisions are based on valid job‐related requirements. If you are a qualified individual with a disability or a disabled veteran and are unable or limited in your ability to use or access our website, you may request a reasonable accommodation to express interest in a specific opening by calling us at (919) 561-6210 or sending us an email at careers@askbio.com.

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