QA Jobs in Durham, NC

Designs, develops, and integrates functional and integration testing for complex software systems. The role creates test plans and cases, debugs and scripts automated tests, evaluates designs against standards, and collaborates with internal and external development teams. It also contributes to software architecture, drives adoption of new technologies, supports cross-organizational initiatives, and mentors junior engineers.

Provide quality assurance oversight for clinical and commercial gene therapy manufacturing. Ensure GMP and regulatory compliance, support audits and inspection readiness, review deviations, CAPAs, change controls, SOPs, and qualification activities, and collaborate with engineering, validation, manufacturing, suppliers, and technical operations to improve quality systems and maintain a compliant production environment.

Provides QA oversight for biopharmaceutical manufacturing operations, focusing on deviations, CAPAs, root-cause investigations, effectiveness checks, change controls, metrics, and GMP compliance. Collaborates with Manufacturing, Engineering, Supply Chain, IT, QC, and other departments to resolve compliance issues, improve systems, support training, respond to client comments, and assist with audits and regulatory inspections.

Lead quality oversight of external aseptic CMOs for sterile fill-finish, ensuring cGMP compliance, managing deviations/CAPAs, reviewing batch records and validations, supporting QP release, conducting audits, driving continuous improvement, and collaborating across Manufacturing, Supply Chain, Regulatory, and Technical Operations.

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

Provides hands-on quality oversight for GMP manufacturing operations, including batch record review and approval, deviation and CAPA investigations, data integrity review, audit and inspection readiness, regulatory compliance, quality metrics analysis, and continuous improvement. Supports media, buffer, cell expansion, upstream, downstream, and aseptic filling operations while partnering with manufacturing teams to ensure compliant production and product quality.

Leads the Quality Assurance department and Quality Management System for manufacturing operations. Responsibilities include ISO 9001 compliance, quality metrics, audits, calibration, nonconformance resolution, 8D corrective actions, root cause analysis, continuous improvement, defect reduction, and production quality improvements. Manages, mentors, and develops the QA team while collaborating with Engineering, Production, customers, and management.

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.

Provides quality assurance and staging services for POS hardware and OEM products. Develops cost-effective quotes, BOMs, engineering changes, routing documents, packaging solutions, and production processes. Reviews customer documentation, validates line build readiness, coordinates pilot runs, approves first article inspections, and supports quality investigations, substitutions, shipping issues, and manufacturing inquiries.

Supports manufacturing quality assurance by implementing and verifying improvement actions, collecting and analyzing data, investigating customer complaints and nonconforming materials, assisting with root-cause and corrective actions, and identifying trends in scrap, defects, rework, and other quality indicators.

Lead and manage regional/global QA programs, audits, SOP authoring, compliance oversight, corrective action review, trend analysis, and cross-functional quality improvement initiatives. Provide regulatory guidance, train stakeholders, oversee QA metrics and customer audits, and manage teams and QA activities to ensure GxP compliance and process quality.

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.

Provides Quality oversight for laboratory, manufacturing, QC, and facilities operations at a cell and gene therapy manufacturing site. Responsibilities include shop-floor presence, batch and logbook review, GMP compliance, product disposition, deviation and CAPA approval, work-order and asset approvals, quality-system improvements, tech transfers, equipment qualification and validation, issue resolution, metrics, and regulatory inspection support. Requires onsite work and a flexible schedule, including alternate shifts.

Maintains the pharmaceutical Quality Management System across manufacturing operations. Responsibilities include validation and qualification review, deviation and OOS investigations, CAPA and change control oversight, batch record review and release, quality risk assessments, supplier quality, internal audits, regulatory inspection readiness, SOP management, and quality trend analysis. The role collaborates with manufacturing, engineering, supply chain, warehouse, and quality control teams to ensure GMP, client, and regulatory compliance.

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 report independent GxP audits across countries; evaluate findings, consult on regulations, manage quality issues (RCA/CAPA), maintain eQMS records, support inspections, train staff, and lead QA improvement projects.

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.