Quality Assurance Associate at Discovery Life Scienes

Woburn, Massachusetts, United States -

Full Time

Start Date

Immediate

Expiry Date

20 Aug, 26

Salary

60000.0

Posted On

22 May, 26

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Assurance, GMP, ISO 9001, CAPA, QMS, Root Cause Analysis, Audit Preparation, Trend Reporting, Microsoft Excel, Microsoft Word, Microsoft PowerPoint, Organizational Skills, Attention To Detail, Technical Writing, Regulatory Compliance, Biologics

Industry

Biotechnology Research

Description

About Discovery Life Sciences: 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. Position Summary: 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. A Day in the Life of a QA Associate at Discovery Life Sciences: * 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) Must-Have Qualifications (Education, Skills, Experience): * 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 Key Responsibilities: * 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 Compensation and Benefits: Discovery Life Sciences is committed to fair and equitable compensation practices, and we strive to provide employees with total compensation packages that are market competitive. For this role, the anticipated base range is $50,000 - $60,000 annually. The base pay range for this position The exact base pay offered for this role will depend on various factors, including but not limited to the candidate's qualifications, skills, and experience. Your annual salary is only one part of your total compensation package. Other benefits: * Competitive salary and benefits package options, including a free dental, vision package, life insurance, and disability coverage which start on your first day of employment. * 401(k) match program which starts on your first day of employment. * Time away from work (Generous vacation and paid time off, paid parental leave, paid family leave, etc.). * Professional development opportunities and reimbursement for relevant certifications and tuition. * Collaborative and inclusive work environment that values diversity. * Team-building activities and social events. * Employee Referral Program and Colleague Recognition Program. Location, work hours, and application details: * This is an onsite position located at Discovery’s Woburn, MA location * Monday – Friday 8am – 5pm * Onsite 5 days per week We are actively seeking motivated, dedicated individuals like you to join our thriving organization. As a leader in our industry, we offer unparalleled opportunities for professional growth and success. Apply Now to join our team! Visit dls.com/careers for more details.

Responsibilities

The QA Associate supports the development and maintenance of the Quality Management System to ensure compliance with ISO 9001 and GLP standards. Key duties include managing CAPAs, performing trend reporting on non-conformances, and assisting with client and surveillance audits.