Quality Management Co-Op RCD QA
Quality Management Co-Op RCD QA
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Job Description
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 limbgirdle 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.
Were 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 6month coop program that will start on July 7th 2025 and conclude on December 19th 2025. This is a fulltime 40 hours a week coop 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 inspectionrelated 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 problemsolving abilities.
What Now
Were always looking for solutionoriented critical thinkers.
So if youre 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.
Employment Type
Full-Time
