Jazz Pharmaceuticals is a global biopharma company that transforms lives by developing life-changing medicines for people with serious diseases.
Job Description:
The Biologics Drug Substance Quality Assurance Specialist plays a key role in ensuring the quality of our products. Working within the External Manufacturing Quality Group, you will oversee contract manufacturing operations and internal quality systems.
Essential Functions/Responsibilities:
* Monitor and support the quality performance of contract manufacturers and material suppliers to GXP standards.
* Review and approve product complaints, deviations, validation protocols, change controls, and lead product-related investigations.
* Collaborate with contract manufacturers, packagers, and testing laboratories to resolve quality issues.
* Ensure compliance with internal Jazz requirements and country-specific regulations.
Key Responsibilities:
* Closely monitor contract manufacturer daily operations.
* Perform batch review and disposition activity.
* Conduct vendor audits and vendor site visits.
* Assist in internal audits and regulatory agency inspections.
* Support the generation of Jazz APQR (Annual Product Quality Review).
* Maintain product-related Quality Technical Agreements (QTAs).
Requirements:
* Strong knowledge of GMP and Regulatory Compliance applicable to the Pharmaceutical/Biotechnology Industry.
* Ability to understand and apply GMP regulations as they relate to manufacturing, QC analytical testing, and facility operations.
* Substantial experience working in or directly supporting manufacturing within a biologics drug substance manufacturing site.
* Experience with contract manufacturing is desirable.
* Significant experience (>5years) of commercial and/or late-state clinical phase GMP manufacturing of biologics drug substance products.
Education and Licenses:
* Bachelor's degree in pharmacy, chemistry, biotechnology, biochemistry, microbiology, or a related discipline.
Jazz Pharmaceuticals is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.
The successful candidate will also be eligible to participate in various benefits offerings, including medical, dental, and vision insurance, retirement savings plan, and flexible paid vacation.