GxP Document Control Co-op

Sarepta Therapeutics
United States, Massachusetts, Andover
Mar 25, 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 The GxP Document Control co-op at Sarepta offers you the chance to lead a project to create and revise all controlled document templates, including policies, standard operating procedures, specifications, test methods, etc. The co-op will use their design skills in Word to enhance formatting and improve user experience to streamline document creation. The co-op will manage controlling (uploading, routing, and approvals) for all templates within Sarepta's electronic Quality Management System (eQMS) and support various day-to-day Document Control Operations. This role will help you learn good documentation practices, understand global regulatory requirements, and sharpen your communication skills by interacting with professionals at all levels of the organization to advance compliance. This is a rare opportunity to collaborate with different departments within Technical Operations and Research & Development organizations to gain comprehensive GxP experience. 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. Designing document templates for critical GxP documentation. Establish minimum content requirements for each document type utilized across Sarepta. Create/revise impacted Standard Operating Procedures (SOPs) that incorporate improvements. Draft presentations and present enhancement updates to personnel; effectively socializing changes made to others. Engage with stakeholders and functional area subject matter experts to ensure templates meet applicable compliance requirements. Perform additional related job duties, as required. More about You Undergraduate (junior or senior) or graduate student pursuing a degree in Business or Life Sciences with a strong interest in the Biotech industry. Ability to strictly adhere to standard operating procedures. Ability to handle a multi-task workload. Strong interpersonal skills and attention to detail. Advanced MS Word experience, creating templates and applying formatting styles. Advanced PDF form design expertise is a plus. 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-MC1 This 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.