GxP Document Control Co-op

Sarepta Therapeutics • Andover, MA

273d • $22 - $34 • Hybrid

About The Position

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.

Requirements

• 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.

Nice To Haves

• Advanced PDF form design expertise.

Responsibilities

• Design 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.

Benefits

• Competitive compensation and benefit package.

What This Job Offers

• Job Type: Full-time
• Career Level: Intern
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree