drjobs GxP Document Control Co-op

GxP Document Control Co-op

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1 Vacancy
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Job Location drjobs

Andover - USA

Hourly Salary drjobs

$ 22 - 34

Vacancy

1 Vacancy

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 GxP Document Control coop 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 coop will use their design skills in Word to enhance formatting and improve user experience to streamline document creation. The coop will manage controlling (uploading routing and approvals) for all templates within Sareptas electronic Quality Management System (eQMS) and support various daytoday 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 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.

  • 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 multitask 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

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.

#LIHybrid#LIMC1

This position is hybrid you will be expected to work on site at one of Sareptas facilities in the United States and/or attend Companysponsored inperson 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 eVerify.

Employment Type

Full-Time

Company Industry

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