Quality Management Co-Op, R&CD QA

Sarepta Therapeutics

Sarepta Therapeutics

Quality Assurance
Cambridge, MA, USA
Posted on Apr 3, 2025

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

We are seeking a motivated and detail-oriented Quality Assurance (QA) Co-Op to join our dynamic team in the Quality Management department. This internship provides an excellent opportunity to gain experience in the biotechnology industry and clinical research via a Quality lens. The Co-Op will gain hands-on experience in clinical quality assurance practices, learn about quality management systems that support clinical trials, and assist with managing Health Authority (e.g., FDA) inspections which lead to drug approvals, and help maintain a culture of quality excellence.

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.

#LI-Hybrid#LI-MC1This position is hybrid, you will be expected to work on site at one of Sarepta’s facilities in the United States and/or attend Company-sponsored in-person events from time to time.The targeted salary range for this position is $22 - $34 per hour depending upon years of education completed and nature of role.Candidates must be authorized to work in the U.S.Sarepta Therapeutics offers a competitive compensation and benefit package.Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify.