Quality Assurance Associate

About Discovery Life Sciences

Discovery Life Sciences is a premier provider of meticulously characterized human biospecimens, cellular starting materials, and research tools aimed at advancing cell and gene therapy as well as precision medicine efforts in cancer, infectious diseases, and other complex conditions. The company manages numerous studies concurrently and expertly analyzes thousands of biospecimens to deliver high-quality products and reliable biomarker data. Their Science at your Service™ model partners with leading biopharma, diagnostic, and academic organizations to accelerate innovation.

Position Summary

The company is seeking an enthusiastic Quality Assurance Associate to help develop and maintain its Quality Management System while ensuring regulatory compliance, including adherence to Good Laboratory Practice and ISO 9001 standards.

Key Responsibilities

• Collaborate with laboratory and operational teams to resolve quality challenges and ensure alignment with GMP and ISO regulations.
• Serve as the Quality representative in cross-functional meetings by offering expert guidance, posing critical questions, and promoting accountability.
• Evaluate quality data such as deviations, complaints, and supplier issues to discern risks and suggest proactive improvements.
• Work jointly with various stakeholders to investigate root causes and implement effective corrective and preventive actions (CAPAs).
• Manage the electronic Quality Management System and support quality initiatives across the Preclinical Boston site.
• Represent Quality in daily operations and meetings addressing quality concerns.
• Assist in preparing for and conducting client audits and annual ISO surveillance audits.
• Partner with colleagues in auditing and rectifying quality issues to enhance internal processes.
• Create controlled documents including procedures and job aids.
• Generate trend reports on non-conformances, supplier challenges, and customer complaints to monitor KPIs and inform management.
• Educate staff about Quality Management Systems through training and presentations.
• Maintain confidentiality of personal information relating to patients, employees, and other parties interacting with the company.

Qualifications and Skills

• Bachelor’s degree in a life sciences discipline or equivalent experience.
• Prior exposure to Quality Assurance principles, GMP, or ISO 9001 environments is preferred.
• Experience working in biologics, preclinical research, or laboratory settings.
• Knowledge of auditing procedures, CAPA processes, and Quality Management System tools.
• Proficiency with Microsoft Office applications including Excel, Word, and PowerPoint.
• Exceptional attention to detail and strong organizational skills with the ability to manage multiple priorities.

Compensation and Benefits

The expected salary range for this position is $45,000 to $60,000 annually, with the precise figure determined based on candidate qualifications and experience. The company offers a competitive benefits package including dental and vision coverage, life insurance, disability coverage starting from day one, a 401(k) match program, generous vacation and paid leave, professional development and tuition reimbursement, an inclusive and collaborative culture, team-building events, and employee recognition programs.

Work Location and Schedule

• This full-time role requires onsite presence at the Woburn, Massachusetts office.
• Standard working hours are Monday through Friday from 8:00 AM to 5:00 PM.
• The position is expected to be onsite five days per week.