QA Engineer

• Ensuring CMOs maintain the highest levels of Quality standards conforming to cGMP and in conjunction with BN QAA
• Support the Bavarian Nordic QPs to enable the release of the highest quality vaccines
• Managing and resolving complex quality-related issues relating to aseptic operations including vial filling and also labelling and secondary packing operations.
• Promoting a strong quality culture and driving continuous improvement initiatives across areas
• Representing QA External Manufacturing in global and cross-organizational forums within Bavarian Nordic
• Review and approve GMP documentation including: Batch records, Deviations, CAPAs, Change controls, Validation protocols and reports
• Ensure compliance with FDA, EU GMP, ICH, and applicable US regulatory requirements
• Participate in risk assessments and investigations related to sterile manufacturing operations
• Collaborate cross-functionally with Manufacturing, Supply Chain, Regulatory Affairs, and Technical Operations teams
• Support technology transfers and process validation activities at external manufacturing sites
• Lead or participate in internal and external GMP audits
• Monitor quality metrics and drive continuous improvement initiatives with manufacturing partners
• Serve as the primary QA liaison between the client and the CMO

QA Specialist – External Manufacturing

• Perform smoke testing and regression testing to validate new releases and feature updates.
• Execute manual test cases for web and mobile applications.
• Identify, document, and report bugs clearly and accurately.
• Support bug triage processes by collaborating with developers and product teams.
• Use test management tools such as TestRail, Zephyr, or Xray to manage and track test cases.
• Work with project management tools like Jira or Asana to log issues and monitor progress.
• Validate functionality across different browsers and mobile devices.
• Use basic browser developer tools to inspect elements, monitor requests, and support troubleshooting.
• Contribute to improving QA processes and documentation standards.

Quality Assurance Analyst

• Design and execute tests for backend systems, including APIs, databases, and service integrations.
• Validate API functionality and performance using tools such as Postman, Swagger, or similar platforms.
• Test and verify database operations, queries, and data integrity in systems using PostgreSQL or similar relational databases.
• Collaborate with engineering teams to review pull requests, ensuring code quality and test coverage.
• Support the development and maintenance of automated tests for backend services.
• Participate in reviewing backend infrastructure and identifying potential reliability or performance issues.
• Document and track defects, test cases, and test results using test management tools such as TestRail or similar systems.
• Work closely with developers and product teams to improve testing strategies and overall product quality.

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QA Specialist – External Manufacturing

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