Vaxess Technologies · 2 hours ago
Quality System Specialist/Senior Quality System Specialist
Woburn, MA
Full-time
Onsite
Mid, Senior Level
$60K/yr - $110K/yr
2+ years expVaxess Technologies is developing next-generation therapeutics on their novel micro-array patch platform. The Quality System Specialist/Senior Quality System Specialist will support and enhance the Quality Management System (QMS) to ensure compliance with GMP/GLP standards, focusing on maintaining electronic quality systems and managing controlled documentation.
BiotechnologyHealth CareMedical
Responsibilities
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
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
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
Qualification
Required
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)
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
Preferred
Experience with electronic quality management systems (e.g., Enzyme, Greenlight Guru, Veeva, MasterControl, etc.) is strongly preferred
Company
Vaxess Technologies
Vaxess Technologies engages in developing biomedical innovations with a focus on improving access to vaccines.
11-50 employees
H1B Sponsorship
Vaxess Technologies has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2024 (1)
2022 (3)
Funding
Current Stage
Growth StageTotal Funding
$95.87MKey Investors
RA Capital ManagementNational Science FoundationThe Engine
2025-04-09Series Unknown· $9M
2024-05-22Series Unknown· $12M
2023-09-13Series Unknown· $9M
Leadership Team
K
Kathryn Kosuda
Co-founder, VP of Research & Development
Livio Valenti
Co-Founder, Senior VP of Strategy, BD and Operations
Recent News
EIN Presswire
2025-06-25
vcnewsdaily.com
2025-04-26
Company data provided by crunchbase