Intern-GCP, GLP Quality Assurance

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 Parkinsons disease and Pompe disease. AskBios 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 peoples 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 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 whats 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.

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 jobrelated 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 or sending us an email at .

Agencies: Please do not contact any employee at AskBio about this requisition. Any resume submitted by a recruitment agency to any employee at AskBio through any medium will be deemed the sole property of AskBio unless the agency was engaged by AskBio Talent Acquisition team to recruit for that position. All agencies must have a prior executed service agreement with AskBio prior to any search engagement. If a candidate who was submitted outside of the AskBio agency process is hired by AskBio no fee or payment of any kind will be paid to the agency.