The Biologics Drug Substance Quality Assurance Specialist is responsible for performing key Quality tasks in respect of Company products. Work in the External Manufacturing Quality Group within the Technical Operations department, which oversees contract manufacturing operations, as well as Internal Quality Systems. Reporting directly to the Associate Director of External Manufacturing Quality Assurance.
Essential Functions/Responsibilities
The position is responsible for monitoring and supporting the quality performance of contract manufacturing organizations and material suppliers to all applicable GXP standards. Responsibilities include:
1. Monitoring the daily operations at the Contract Manufacturer, performing batch review and disposition, reviewing and approving product complaints, deviations, Validation protocols, change controls, and leading product-related investigations.
2. CMO Batch file review and associated lot disposition activity.
3. Ensuring compliance of all respective contract manufacturers to both internal Jazz requirements and country-specific regulations.
4. Collaboration with all contract manufacturers, packagers, and testing laboratories to resolve any quality issues.
5. Contributing to the successful outcome of all regulatory inspections associated with company business, both internally and at contract manufacturers, as required.
6. Highlighting any risks associated with maintaining supply of commercial drug products to all markets.
7. Conducting vendor audits and vendor site visits as required.
8. Assisting in internal audits and regulatory agency inspections.
9. Summarizing CMO Annual Product Quality Reviews and supporting regulatory submissions.
10. Assisting with the generation of Jazz APQR (Annual Product Quality Review).
11. Maintaining product-related Quality Technical Agreements (QTAs).
12. Understanding new regulations and guidelines as they apply to the company business and implementing systems and procedures to incorporate these new regulations as appropriate.
13. Reviewing and approving moderated complexity deviations and associated corrective actions.
14. Reviewing and approving less complex validation documents.
15. Supporting the generation of new, as well as improvement of, existing department SOPs.
16. Supporting delivery of projects.
17. Working with management to resolve project issues and resource constraints within the team.
18. Liaising with internal and external stakeholders to resolve and clarify any points of issue.
19. Reviewing and approving executed batch records and product testing records.
20. Dispositioning lots.
21. Partnering with other departments/groups to problem-solve and address moderately complex issues.
22. Collaborating in the continuous improvement of the QA processes, identifying opportunities and leading them to implementation.
23. Representing QA in cross-functional project teams for moderately difficult projects.
24. Participating in and facilitating regulatory inspection readiness.
25. Coordinating and collaborating with other teams to meet organizational goals and work requirements.
26. Receiving assignments in the form of objectives and determining how to use resources to meet schedules and goals.
27. Demonstrating success using compliance knowledge, creativity, and regulatory perspectives to solve problems, especially those associated with major and critical deviations.
28. Following processes and operational policies in selecting methods and techniques for obtaining solutions; solving moderately complex problems and identifying viable and often innovative options.
29. Using analytical skills and judgment to recommend the "best" solution.
30. Maintaining quality from cell banking through to production and post-release events (e.g., stability, product complaints).
Required Knowledge, Skills, and Abilities
- Strong knowledge of GMP and Regulatory Compliance as applicable to the Pharmaceutical/Biotechnology Industry.
- Ability to understand and apply GMP regulations as they relate to manufacturing, QC analytical testing, and facility operations, with deep knowledge of biologics drug substance manufacturing.
- Substantial experience working in or directly supporting manufacturing within a biologics drug substance manufacturing site.
- Experience with contract manufacturing is desirable.
- Significant experience (>5 years) of commercial and/or late-stage clinical phase GMP manufacturing of biologics drug substance products.
- Highly organized, with exceptional time management and prioritization.
- Excellent verbal and written communication skills.
Required/Preferred Education and Licenses
- Bachelor's degree in pharmacy, chemistry, biotechnology, biochemistry, microbiology, or a related discipline.
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