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Quality System Specialist / Senior Quality System Specialist
Quality System Specialist / Senior Quality System SpecialistVaxess Technologies • Woburn, MA, US
Quality System Specialist / Senior Quality System Specialist

Quality System Specialist / Senior Quality System Specialist

Vaxess Technologies • Woburn, MA, US
[job_card.30_days_ago]
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  • [job_card.full_time]
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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

  • Manage the full lifecycle of controlled documents, including creation, revision, review, approval, distribution, and archival within the electronic document management system (EDMS).
  • Ensure that controlled documents, such as SOPs, batch records, and specifications, are accurate, current, and compliant with regulatory and internal requirements.
  • Coordinate document workflows with cross-functional teams to ensure timely completion and alignment with procedural requirements.
  • Author or revise SOPs, forms, and work instructions supporting quality system and GMP operations.

    • Training and Compliance Support

  • Provide training and day-to-day support to employees on document control and system processes.
  • Serve as a subject matter expert (SME) for document control and computerized systems during internal and external audits and inspections.
  • Support tracking and reporting of quality metrics (e.g., training completion, document cycle time, CAPA effectiveness) to drive continual improvement.

    • Qualifications :

  • Bachelor’s degree in Life Sciences, Engineering, or a related discipline preferred; equivalent work experience considered.
  • 2–5 years of experience in a GMP, GLP, or GxP-regulated environment (pharmaceutical, biotechnology, or medical device industry).
  • Experience with electronic quality management systems (e.g., Enzyme, Greenlight Guru, Veeva, MasterControl, etc.) is strongly preferred.
  • Familiarity with relevant regulations and standards (21 CFR Parts 210 / 211 / 11 / 820; ISO 9001 / 13485).
  • Excellent attention to detail, organization, and communication skills; ability to manage multiple priorities in a dynamic environment.
  • Collaborative, proactive, and adaptable work style aligned with a fast-paced, innovation-driven company.

    • 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 .

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    Quality System Specialist • Woburn, MA, US

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