Intern - Quality Management System (QMS)

United States·Cambridgeentry

OperationsManagement

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Overview

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OperationsManagement

Alkeus Pharmaceuticals, Inc. is a clinical-stage biotech company focused on the development of innovative therapies to treat serious diseases of the eye with high unmet need. Based in Cambridge, Mass., Alkeus was founded in 2010, and since that time has been developing its lead compound, gildeuretinol acetate (ALK-001). Designated as a breakthrough therapy and granted orphan drug status by the U.S. Food and Drug Administration, gildeuretinol is being evaluated in multiple clinical trials for the treatment of Stargardt disease and geographic atrophy (GA) secondary to age-related macular degeneration (AMD), a leading cause of blindness in the U.S.

The Quality Management System Intern is responsible for supporting GxP document migration activities into the electronic Quality Management System (eQMS) and assisting in maintaining accurate, organized, and compliant quality documentation.

Responsibilities

~1 min read

→Support the migration of quality documents into the eQMS (Dot Compliance), ensuring accuracy and completeness
→Assist in organizing and categorizing documents according to established quality and regulatory standards
→Perform data entry and verification to ensure proper metadata assignment and document traceability
→Review documents for formatting consistency and completeness prior to upload
→Collaborate with quality team members to resolve discrepancies or missing information
→Maintain organized tracking tools (e.g., logs or trackers) for document migration progress
→Develop and maintain training materials to support the effective rollout and adoption of new systems
→Ensure adherence to internal SOPs and data integrity principles throughout all activities
→Deliver on other related projects as assigned

Requirements

~1 min read

Education and Certification
- Currently pursuing a bachelor’s or master’s degree in quality assurance, pharmaceutical sciences, or related fields
Work Experience
- Experience with Microsoft Excel
- Demonstrated experience working with electronic systems and maintaining high levels of accuracy
- Demonstrated record of strong analytical and problem-solving skills
Skills and Key Success Factors
- Entrepreneurial spirit with a passion to build, learn and evolve with the team
- Highly organized and detail oriented with a passion to deliver quality results
- Excellent verbal and written communication skills, with experience translating complex concepts for various audiences
- Demonstrated record of intellectual curiosity, innovation and creative problem solving with a sense of initiative and ownership
- Ability to lead fast-paced projects with a keen sense of urgency to get the job done well
- Evidence of "hands-on" experience and expertise
- Proven and successful track record as a team-player and collaborator in small working environments
- Highest levels of professionalism, confidence, personal values and ethical standards