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Quality Operations Co-op, Gene Therapy

Sarepta Therapeutics
Cambridge, MA Full Time
POSTED ON 3/28/2025 CLOSED ON 4/22/2025

What are the responsibilities and job description for the Quality Operations Co-op, Gene Therapy position at 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 Quality Assurance Operations co-op provides students with an overview of Gene Therapy Manufacturing - Quality Assurance responsibilities including general knowledge of Quality Review Process of GMP Production Batch Records and Change Controls. The co-op will receive hands-on experience in developing the skills to lead and drive Continuous Improvement initiatives aimed at Error Reduction and Quality Review optimization. In addition, the co-op will have a unique networking opportunity to manage their own project by working in cross-functional teams to support the timely release of high-quality products to serve patients globally.

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.

  • Review production paperwork, such as batch records for completeness and correctness.

  • Assist in projects aimed at improving efficiency, lowering errors, and optimizing process quality.

  • Prepare for internal and external quality audits by gathering necessary documentation and ensuring compliance.

  • Strong capacity to spot mistakes and discrepancies in information and records.

  • Analyze data, identify trends, and draw meaningful conclusions.

  • Support CMO vendor oversight.

More about You

  • Graduate student pursuing a degree in science, technology, or engineering and has an undergraduate degree in science, technology, or engineering.
  • Fundamental knowledge of current Food and Drug Administration (FDA) regulations, and guidelines, is desired.
  • Strong communication and interpersonal skills, highly motivated, and a self-starter.
  • Able to work independently, take initiative and drive for results with minimal supervision
  • Strong written and verbal communication skills, with ability to work in teams and to effectively interact with employees.
  • Proficient in MS Office programs - Outlook, Word, Excel, PowerPoint
  • Must possess excellent organization skills and ability to manage multiple ongoing tasks and prioritize based on shifting demands.

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-Remote#LI-MC1

This position is remote. However, 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.

 

Salary : $22 - $34

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