Quality Assurance Specialist

Discovery Life Sciences • , AL

10d • $70,000 - $85,000 • Hybrid

About The Position

Discovery Life Sciences is seeking a Quality Assurance Specialist to support the quality and compliance of its Specialty Lab Services operations. The role provides routine quality support to advanced technical laboratories—including Flow Cytometry, Proteomics, and Genomics—which perform research and retrospective and prospective clinical testing. Responsibilities include supporting and hosting external audits, managing U.S. supplier qualification activities, and overseeing change management processes.

The position requires experience with Flow Cytometry to support effective collaboration with laboratory subject matter experts and practical application of quality requirements in a technical laboratory environment. As part of the Global Quality & Regulatory team, the Specialist also supports investigations and CAPAs, computerized systems validation, documentation and data review, and continuous quality improvement.

Requirements

• Bachelor's degree in Life Sciences or a related scientific discipline.
• Minimum of 5 years of Quality Assurance experience in pharmaceutical, biotechnology, clinical research, clinical laboratory, diagnostic, CRO, or another regulated scientific environment.
• Strong hands-on experience supporting GCP-regulated activities and demonstrated understanding of ICH-GCP requirements and quality principles.
• Familiarity with Flow Cytometry, preferably in a CAP/CLIA setting, gained through direct laboratory technical experience or quality support.
• Strong working knowledge of Quality Management Systems and applicable regulations and standards, including FDA and ICH requirements, EU MDR, IVDR, CAP/CLIA, GCP, GCLP, and ISO 13485.
• Experience supporting audits before, during, and after audit requests; hosting sponsor, health authority, or accreditation audits; and conducting internal and supplier/service-provider audits.
• Strong background and expertise in change management and the ability to communicate complex quality principles clearly to diverse stakeholders.
• Prior experience with NCEs, deviations, investigations and root cause analysis, and CAPA management.
• Ability to travel up to 10% domestically and internationally for mandatory site meetings and training.
• Work authorization sponsorship is not available; the company is unable to sponsor or take over sponsorship of applicant work visas.

Nice To Haves

• Certified Quality Auditor (CQA) or comparable professional quality certification.
• Working knowledge of computerized systems validation, including planning, execution, documentation, and compliance with requirements such as 21 CFR Part 11 and GxP.

Responsibilities

• Maintain, monitor, and support adherence to the Quality Management System across Specialty Lab Services operations.
• Ensure compliance with applicable regulations, accreditation standards, customer requirements, and internal quality procedures, including GCP, GCLP, CAP/CLIA, ISO 13485, and ISO 15189.
• Maintain complete and accurate quality records and provide laboratory personnel with quality guidance and training.
• Serve as the primary Quality Assurance partner for Flow Cytometry operations, providing day-to-day quality support and consultation.
• Collaborate with laboratory subject matter experts to integrate quality requirements into laboratory processes using practical, risk-based solutions.
• Support laboratory quality activities, including deviations, non-conformances, investigations, CAPAs, training, metrics, document review, and compliance initiatives.
• Support harmonization and expansion of Flow Cytometry services across global laboratory locations.
• Lead and support external sponsor, customer, accreditation, and regulatory audits, including preparation, hosting, document retrieval, issue resolution, and post-audit follow-up.
• Conduct and participate in internal audits, identify opportunities for continuous improvement, and drive audit readiness.
• Facilitate investigations of deviations, non-conformances, quality events, and compliance concerns.
• Partner with cross-functional teams on root cause analyses and development of corrective and preventive actions.
• Monitor CAPA implementation and effectiveness and analyze quality metrics and operational data to identify trends, risks, and improvement opportunities.
• Provide global oversight of change management, ensuring changes are assessed, documented, approved, implemented, and monitored.
• Evaluate the quality and regulatory impact of proposed changes and advise on mitigation strategies.
• Support computerized systems validation and IT change control, including review of validation documentation and quality guidance to laboratory and technical stakeholders.
• Manage U.S. supplier qualification activities and conduct supplier audits; support supplier performance monitoring and global qualification initiatives.
• Partner with internal stakeholders to assess and manage vendor and service-provider quality risks.
• Review and approve SOPs, forms, validation documents, study documentation, laboratory data, reports, and analytical plans for accuracy, completeness, and compliance.
• Ensure controlled documents are current, maintained, and aligned with regulatory and business requirements, and support document management in electronic QMS and controlled documentation systems.

Benefits

• Competitive salary and benefits package.
• Free dental and vision package, life insurance, and disability coverage beginning on the first day of employment.
• Eligibility for discretionary performance-based incentive compensation, which may include cash bonuses.
• 401(k) match program beginning on the first day of employment.
• Generous vacation and paid time off, paid parental leave, and paid family leave.
• 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.

What This Job Offers

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