Intern-GCP, GLP Quality Assurance

Asklepios BioPharmaceutical, Inc. (AskBio)•Durham, NC

3d•Onsite

About The Position

AskBio Inc., a wholly owned and independently operated subsidiary of Bayer AG, is a fully integrated gene therapy company dedicated to developing life-saving medicines and changing lives. The company maintains a portfolio of clinical programs across a range of neuromuscular, central nervous system, cardiovascular, and metabolic disease indications with a clinical-stage pipeline that includes investigational therapeutics for congestive heart failure, limb-girdle muscular dystrophy, multiple system atrophy, Parkinson’s disease, and Pompe disease. AskBio’s gene therapy platform includes Pro10™, an industry-leading proprietary cell line manufacturing process, and an extensive array of capsids and promoters. With global headquarters in Research Triangle Park, North Carolina, and European headquarters in Edinburgh, Scotland, the company has generated hundreds of proprietary capsids and promoters, several of which have entered pre-clinical and clinical testing. Our vision: Pioneering science to create transformative molecular medicines. Our mission: Lead innovative science and drive clinical outcomes to transform people's lives. Our principles: Advance innovative science by pushing boundaries. Bring transformative therapeutics to patients in need. Provide an environment for employees to reach their fullest potential. Our values: Be a Pioneer. We are not afraid of the impossible and to innovate to make gene therapies accessible to those in need. Cultivate Collaboration. Strive to be the best teammate, actively listen, openly communicate, and embrace diverse points of view. Embrace Responsibility. We are humbled by the enormity of our mission. We hold a relentless commitment to advance science and clinical outcomes for our patients, families, and caregivers. Raise the Bar. Continuously drive improvements and efficiencies. Seek and provide constructive feedback. Have a bias for learning and action. Act with Uncompromising Integrity. Be honest, transparent, and committed to doing what’s right in every situation. Make clear commitments and follow through. 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.

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)

Nice To Haves

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

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.