Quality System Specialist / Senior Quality System Specialist

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 array 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.