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.

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.

Lead design, develop, and maintain automated test frameworks for web apps and APIs. Integrate automation into CI/CD pipelines, execute complex manual/automated tests, coordinate test plans, mentor team members, perform risk analysis and drive quality process improvements.

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.

Lead Quality Assurance for Small Molecule Operations, ensuring compliance with cGMP and regulatory standards while overseeing a high-performing QA team.

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

Lead design and delivery of end-to-end test automation and frameworks (API and UI). Manage QA teams, define test strategies, oversee DR validations, coordinate cross-team testing, advise senior management on QA strategy, and implement test automation using Java, Cucumber, REST Assured, Selenium, AWS/Kubernetes, Python and related tools.

Analyze requirements and functional/technical specs to develop test conditions, cases, and automated scripts. Execute manual and automated tests (web, GUI, client/server, database), validate results via SQL and UNIX, report and track defects, review test artifacts, and ensure testing adherence to project schedules and standards.

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.

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 QA efforts by designing and implementing test automation frameworks, executing manual and automated tests, integrating tests into CI/CD pipelines, coordinating regression and environment validation, mentoring team members, reporting test status and risks, and driving quality process improvements to ensure on-time, on-budget delivery.

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

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.