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Quality System Specialist / Senior Quality System Specialist

Quality System Specialist / Senior Quality System Specialist

Vaxess TechnologiesWoburn, MA, US
18 hours ago
Job type
  • Full-time
Job description

Job Description

Department : Quality Assurance

Location : Woburn, MA

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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