Quality Assurance Associate performing functional testing on online courseware for LRN, a leading ethics and compliance SaaS company, ensuring all elements work correctly and meet quality standards.
About the role
- Quality Engineer providing oversight on Computer System Validation at Kite Pharma. Facilitating compliance, innovation, and quality assurance in cancer treatment developments.
Responsibilities
- Provide quality oversight for enterprise, cross-functional, and site-level computer system validation activities, ensuring alignment with GMP, 21 CFR Part 11, Annex 11, Data Integrity principles, and applicable industry guidance.
- Support and apply a risk-based approach to the qualification, validation, and lifecycle management of enterprise.
- Ensure GMP-relevant computer systems comply with regulations, internal procedures, and industry best practices.
- Review and assess proposed changes to validated systems, determining appropriate levels of validation, testing, and documentation required.
- Review technical documentation, workflow diagrams, test requirements, and resource needs to support validation and change-control activities.
- Review and approve validation deliverables—including Validation Plans, Qualification Protocols, UAT Plans and Test Cases, Traceability Matrices, and Validation Summary Reports—to ensure compliance and quality standards.
- Drive innovation and process optimization related to validation and testing approaches, including adoption of automation, streamlined testing strategies, and Computer Software Assurance (CSA) principles.
- Support implementation, validation, and integration of Manufacturing Automation Systems and their interoperability with enterprise platforms.
- Serve as the validation representative on project teams, providing cGMP and CSV expertise during system design, implementation, configuration, and lifecycle activities.
- Provide quality oversight and support for new system introductions, upgrades, enhancements, and system retirement activities.
- Act as Quality Reviewer/Approver for validation activities within the QMS.
- Provide quality oversight during change control execution to ensure accurate technical impact assessments, proper documentation, and validated state maintenance.
- Support internal and external audits, regulatory inspections, and inspection-readiness activities.
- Drive continuous improvement initiatives related to CSV, data integrity, system lifecycle management, and QMS processes.
- Support Data Integrity governance activities, including ALCOA+ compliance, DI risk assessments, periodic reviews, and system-level controls.
- Participate in system lifecycle activities such as periodic reviews, access reviews, backup/restore testing, disaster recovery validation, and retirement planning.
- Support supplier qualification activities for GxP-relevant cloud, SaaS, or vendor-managed systems, including participation in vendor audits.
- Collaborate with IT Security to ensure appropriate cybersecurity controls for GxP systems (e.g., identity management, audit trails, vulnerability assessments).
- Contribute to development, review, and improvement of procedures, work instructions, templates, and training related to CSV, data integrity, and GxP system governance.
- Partner with IT and business owners to support service levels, incident management, deviation handling, and problem resolution in alignment with ITIL principles.
- Communicate effectively with functional teams, leadership, and global partners to ensure alignment, transparency, and collaborative problem-solving.
- Perform other duties as assigned.
Requirements
- Master’s degree and 4+ years of Computer Systems experience OR Bachelor’s degree and 6+ years of Computer Systems experience OR Associate degree and 8+ years of Computer Systems experience OR High School Diploma/GED and 10+ years of Computer Systems experience
- Experience in software quality assurance or quality oversight roles within a biopharmaceutical environment
- 5+ years in an FDA-regulated environment with strong understanding of cGxP standards and risk-based validation principles
- Demonstrated ability to review validation documentation, lifecycle deliverables, deviations, and non-conformances
- Strong critical thinking, troubleshooting, and problem-solving skills
- Self-motivated and adaptable, with willingness to take on responsibilities beyond initial job scope
- Prior experience with enterprise systems (e.g., ERP, LIMS, MES, QMS).
- Excellent interpersonal, verbal, and written communication skills
- Comfortable working in a fast-paced and dynamic environment.
Benefits
- company-sponsored medical, dental, vision, and life insurance plans*
- discretionary annual bonus
- discretionary stock-based long-term incentives (eligibility may vary based on role)
- paid time off
Job title
Job type
Experience level
Salary
Degree requirement
No Education Requirement
Tech skills
Location requirements
Teamlead QA responsible for leading QA activities and establishing a sustainable quality strategy at apo.com Group. Working collaboratively with development and product management in a hybrid work environment.
IT Business Analyst/QA specialist within SEB’s Calypso team, supporting trading and post - trade processing for capital markets products. Collaborating with an international Agile SCRUM team on quality assurance activities.
QA Tester focusing on test automation within a societal critical IT environment. Involves working closely with a development team across all stages from planning to execution.
Project Quality Assurance Engineer at CROWDCONSULTANTS ensuring quality compliance in space projects. Supporting QA activities across the engineering lifecycle in a regulated environment.
Lead QA Engineer overseeing test planning and execution for Salesforce applications in a fast - paced environment. Collaborating with multiple teams to guarantee quality and adherence to standards.
Sr Manager of QA Engineering leading quality assurance for Salesforce at Lennar. Overseeing QA engineers, implementing testing frameworks, and ensuring quality standards.
Senior QA Engineer responsible for executing high - quality testing strategies across Salesforce platforms at Lennar. Collaborating with teams to validate complex Salesforce solutions and ensure quality standards are met.
Penetration Tester performing security assessments across applications and networks for PCI compliance. Collaborating with teams to identify vulnerabilities and strengthen security posture in a flexible, supportive environment.
Senior QA Engineer in Nasdaq's MPP Engineering team ensuring the quality and reliability of critical US trading infrastructure by conducting testing and supporting troubleshooting efforts.