Quality Assurance Associate

Discovery Life Sciences • Woburn, MA

6d • Onsite

About The Position

Discovery Life Sciences (Discovery) is a leading provider of highly characterized human biospecimens and cellular starting materials to advance cell and gene therapy and precision medicine programs for cancer, infectious disease, and other complex conditions. We routinely manage hundreds of studies and expertly test thousands of biospecimens simultaneously. Leading biopharma, diagnostic and academic institutions trust us to quickly deliver high-quality biospecimens and reliable, reproducible biomarker data, so they can outpace their competition and push the leading edge of innovation using our Science at your Service TM business model. Discovery is looking for a talented and passionate Quality Assurance Associate (QA Associate) to join our team. The Quality Associate contributes to our mission by assisting in the development and maintenance of the company’s Quality Management System and ensuring compliance with regulatory requirements, including but not limited to: Good Laboratory Practice, ISO 9001.

Requirements

• 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

Responsibilities

• Partner with lab and operations teams to troubleshoot real-time quality issues and ensure compliance with GMP and ISO standards
• Participate in cross-functional meetings as the voice of Quality—providing guidance, asking the right questions, and driving accountability
• Analyze quality data trends (e.g., deviations, complaints, supplier issues) to identify risks and proactively recommend improvements
• Collaborate with stakeholders to investigate root causes and develop meaningful corrective and preventive actions (CAPAs)
• Support quality initiatives and be an advocate for quality throughout Preclinical (Boston)
• Maintain electronic Quality Management System
• Respond to daily quality issues including representing Quality in various meetings
• Assist in leading initiatives and maintaining quality systems in accordance with applicable regulatory standards (i.e., ISO, GLP)
• Assist in preparation for and hosting client audits and annual ISO surveillance audits
• Collaborate with colleagues to audit, identify and correct quality issues and improve internal processes
• Develop procedures, job-aids and other controlled documents
• Perform trend reporting of non-conformances, supplier issues and customer complaints etc. to track KPIs and flag quality concerns to be presented to department managers and executives
• Review and support investigations/CAPAs of non-conformances, supplier issues and customer complaints and recommend corrective actions
• Support to departments during implementation of quality tasks.
• Educate employees on Quality Management System through training and presentations
• Respect the privacy of the personal information of patients, co-workers, and all individuals with whom the Company interacts

Benefits

• Competitive salary and benefits package options
• free dental, vision package
• life insurance
• disability coverage
• 401(k) match program
• Generous vacation and paid time off
• paid parental leave
• paid family leave
• Professional development opportunities
• reimbursement for relevant certifications and tuition
• Collaborative and inclusive work environment that values diversity
• Team-building activities and social events
• Employee Referral Program
• Colleague Recognition Program

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level