QA Jobs in Durham, NC

The Executive Director provides leadership for Quality Assurance and Regulatory Compliance in Clinical Pharmacology Services, ensuring a quality management system aligned with regulations and business strategy. Responsibilities include overseeing QA audits, compliance risks, and employee management, while fostering a culture of quality and operational excellence.

Support planning and execution of GxP quality assurance audits: schedule and document audits, perform data and file reviews, enter findings into eQMS, assist CAPA review and closure, host audits/inspections, and maintain QA documentation and compliance tracking.

The QA Test Lead oversees the testing process, analyzes business requirements, develops test conditions, and manages test case execution and reporting for software quality assurance.

Assist in ensuring quality in mobile and web applications as a QA Analyst by creating test plans, executing tests, and documenting issues.

Plan, conduct, and close independent GCP clinical audits across contracted countries; prepare and distribute audit reports; provide regulatory interpretation and consultation; review and track RCA/CAPA/EC plans; maintain eQMS; lead QA initiatives, training, and support inspections and corrective actions to ensure compliance with regulations, SOPs, and customer requirements.

Plan and conduct audits for compliance, provide consultation on regulations and policies, manage quality issues, and lead training initiatives.

The Sr. Specialist I, PQA will oversee quality in manufacturing, ensure compliance with GMP, manage deviations, and support regulatory inspections.

The Manufacturing Quality Assurance Specialist supports the manufacturing process, ensures compliance, guides manufacturing teams, and executes core QA activities including record review and resolution of deviations.

The MQA Specialist supports manufacturing by ensuring compliance, performing record reviews, and providing real-time guidance on GMP activities. Responsibilities include batch record approval, deviation triage, and interdepartmental collaboration.

The Senior QA Specialist reviews and approves Deviations and CAPAs for GMP manufacturing, mentors staff, and collaborates to streamline processes.

The Principal QA Specialist ensures compliance of Biopharmaceutical GMP data, oversees lab activities, and supports product lifecycle while collaborating with various stakeholders.

The Senior QA Specialist ensures compliance and quality in vaccine production by managing CMO oversight, resolving quality issues, and driving improvements.

The Sr Quality Assurance Engineer ensures compliance with quality standards, implements quality management systems, conducts audits, and resolves supplier issues, promoting continuous improvement.

Client-facing QA lead ensuring cGMP and regulatory compliance. Supports product release, deviation investigations, CAPA review/approval, audit/inspection readiness, and compiles/analyzes Quality and Client metrics including Annual Product Quality Reviews. Interfaces across global functions to resolve quality issues and report status.

Lead design, development, testing and integration of complex software systems. Manage project teams and outsourced partners, provide systems architecture expertise, drive technology adoption, and mentor junior engineers while ensuring quality and compliance with design standards.

The QA Specialist II ensures compliance through reviewing and approving GMP data, method qualifications, validations, and laboratory investigations in biopharmaceutical development.

Responsible for quality assurance reviews of account onboarding, ensuring compliance with BSA/AML regulations, and managing documentation and remediation efforts.