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Job Description
Join Jazz Pharmaceuticals as a Senior Quality Assurance Specialist, where you'll play a crucial role in ensuring the quality and compliance of biologics drug substance manufacturing. You'll oversee contract manufacturers, support regulatory inspections, and collaborate with teams to enhance quality assurance processes.
Key Responsibilities
Monitor and support quality performance of contract manufacturing organizations
Perform batch review and disposition
Review and approve product complaints, deviations, and validation protocols
Conduct vendor audits and site visits
Collaborate with manufacturers and testing labs to resolve quality issues
Participate in regulatory inspections and maintain compliance
Summarize CMO Annual Product Quality Reviews
Required Qualifications
Strong knowledge of GMP and Regulatory Compliance in Pharmaceutical/Biotechnology Industry
Ability to apply GMP regulations to manufacturing and QC testing
Substantial experience in biologics drug substance manufacturing
Significant experience (>5 years) in GMP manufacturing of biologics drug substance products
Excellent verbal and written communication skills
Highly organized with exceptional time management
Preferred Qualifications
Experience with contract manufacturing
Benefits & Perks
Medical, dental, and vision insuranceRetirement savings planFlexible paid vacation