Quality System Specialist / Senior Quality System Specialist

Job Description

Department : Quality Assurance

Location : Woburn, MA

Vaxess is a NIH and venture-funded company developing a pipeline of next-generation vaccines and therapeutics on the MIMIX platform. With only five minutes of wear-time on the skin, the self-applied MIMIX patch enables up to two weeks of sustained delivery. The platform combines high temperature stability with simplified application to dramatically alter the way that drugs are delivered. Vaxess is committed to enabling products that are not only more effective, but also more accessible to patients around the world.

The Quality System Specialist / Senior Quality System Specialist plays a key role in supporting and enhancing Vaxess Technologies’ Quality Management System (QMS) to ensure compliance with applicable GMP / GLP standards. This position focuses on maintaining robust electronic quality systems, managing controlled documentation, and supporting the integration of new processes and applications.

Key Responsibilities :

Quality System and Computerized System Oversight

• Support quality oversight for computerized systems, including QMS implementation, configuration, validation, and data migration activities.
• Assist in launching new or enhanced system functionalities and communicating updates or user guidance to ensure effective adoption.
• Collaborate with internal stakeholders and system vendors to ensure integrated processes across modules (Document Control, Training, Equipment, and Material Management).
• Troubleshoot and resolve user issues as needed.

Documentation and Record Management

Training and Compliance Support

Qualifications :

Vaxess, a venture-backed life sciences company, is building a team of exceptional people to rapidly advance products on its microneedle platform. We work closely as a team and thrive in a dynamic, exciting, and engaging work environment. If you’re interested in joining the Vaxess team, please submit your CV / resume to careers@vaxess.com .