4 дня назад
Quality Systems Specialist
101 500 - 131 500$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Quality Systems Specialist (Biotech/Quality Systems): Managing controlled documents, quality records, and electronic quality management systems for regulated manufacturing with an accent on document lifecycle control, cGMP compliance, and inspection readiness. Focus on administering MasterControl and Veeva, maintaining audit-ready records, supporting training and audits, and improving quality system operations.
Location: Framingham, Massachusetts, United States; on-site
Salary: $101,500–$131,500 annual base pay
Company
is a biotechnology company developing oncolytic immunotherapies designed to activate systemic anti-tumor responses and transform cancer treatment.
What you will do
- Archive, organize, route, review, and maintain controlled documents and quality records.
- Coordinate document preparation, shipment, storage, retrieval, and retention with off-site archival facilities.
- Administer MasterControl workflows, user access, training assignments, document formatting, and troubleshooting.
- Create and maintain logbooks, laboratory notebooks, batch records, training materials, reports, dashboards, and quality metrics.
- Support internal and external audits, inspection readiness, employee onboarding training, and cross-functional quality system activities.
- Contribute to continuous improvement projects across multiple sites.
Requirements
- Bachelor’s degree with practical experience in a regulated manufacturing environment, or equivalent experience.
- At least 4 years of relevant experience.
- Strong organization, prioritization, time management, communication, and attention-to-detail skills.
- Proficiency with Microsoft Word, Excel, PowerPoint, Access, and Outlook.
- Ability to resolve issues proactively and work independently across multiple projects.
- Ability to lift approximately 15 pounds.
Nice to have
- Experience with electronic document and quality management systems, especially MasterControl and Veeva.
Culture & Benefits
- Mission-driven work focused on improving cancer treatment and patient outcomes.
- Collaborative, bold, committed, and candid working culture.
- Medical, dental, and vision insurance.
- 401(k) match, flexible time off, paid holidays, and year-end shutdown.
- Annual performance incentive bonus and equity eligibility.
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