Quality Assurance Associate
$50,000–$60,000 year
On-site · Woburn, Massachusetts, United States
Job Summary
Quality Assurance Associate to develop and maintain the company’s Quality Management System and ensure regulatory compliance (GMP and ISO 9001). Responsibilities include partnering with lab/operations to troubleshoot real-time quality issues, guiding cross-functional quality discussions, analyzing quality data trends to identify risks, investigating root causes, and developing CAPAs; assisting with client audits and ISO surveillance audits; supporting task-based quality initiatives and training across Preclinical operations (Boston) and maintaining electronic QMS. Requires a Bachelor’s degree in life sciences (or equivalent), QA/GMP/ISO exposure, and strong documentation/communication skills. Base salary range is $50,000-$60,000 with benefits including 401(k) match and comprehensive medical/dental coverage; onsite at Woburn, MA, with traditional M-F hours.
Required Qualifications
- Bachelor’s degree in a life sciences field OR equivalent experience
- Exposure to Quality Assurance, GMP, or ISO 9001 environments preferred
- Experience in biologics, preclinical, or laboratory settings
- Familiarity with audits, CAPA processes, and QMS tools
- Excellent computer skills, including Microsoft Excel, Word and PowerPoint
- Strong attention to detail with excellent organizational skills and the ability to prioritize multiple tasks
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