Quality Management Co-Op, R&CD QA
Sarepta Therapeutics
Why Sarepta? Why Now?
The promise of genetic medicine has arrived, and Sarepta is at the forefront. We hold leadership positions in Duchenne muscular dystrophy (DMD) and limb-girdle muscular dystrophies (LGMDs), and we currently have more than 40 programs in various stages of development in gene therapy, RNA and gene editing. In 2023, we launched our fourth therapy and the first ever gene therapy to treat Duchenne.
We’re looking for people who see unlimited potential in themselves and who are motivated by an unwavering commitment to patients.
What Sarepta Offers
At Sarepta, we care deeply about all the people in our community and believe in the importance of supporting them in all aspects of their lives. We aspire to maintain a culture that acknowledges people bring their whole selves to work, and we will strive to help everyone in our community integrate their work and personal lives while maintaining productivity.
The Importance of the Role
The Opportunity to Make a Difference
This application is for a 6-month co-op program that will start on July 7th, 2025, and conclude on December 19th, 2025. This is a full-time, 40 hours a week, co-op program.
Assist in maintaining inspection readiness and ensuring compliance with regulatory requirements.
Help with the organization, review, and maintenance of quality documents, including Standard Operating Procedures (SOPs), work instructions, and inspection readiness materials.
Support the QA team in preparing and delivering training materials for employees on inspection readiness procedures and compliance requirements.
Assist with data entry, tracking, and trending of inspection-related activities, findings, and corrective/preventive actions (CAPAs).
Contribute to quality improvement initiatives and identify opportunities for streamlining inspection readiness processes.
More about You
Undergraduate (senior) or graduate student pursuing a degree in Life Sciences, Pharmacy, Engineering, or a related field.
Previous internship or coursework in quality assurance, regulatory compliance, or the pharmaceutical/biotech industry is a plus but not required.
Strong attention to detail and organizational skills.
Ability to communicate effectively both verbally and in writing.
Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
Familiarity with regulatory standards such as GCP (Good Clinical Practice), FDA, and EMA is a plus.
Strong analytical and problem-solving abilities.
What Now?
We’re always looking for solution-oriented, critical thinkers.
So, if you’re comfortable with ambiguity and candor, relish challenging yourself, and place kindness and integrity at the forefront of how you approach your peers and work, then we encourage you to apply.