Quality Control Specialist

Description

• Management of stability programs for assigned products in External Manufacturing Operations
• Support the resolution of out-of-specification (OOS)/out of trends (OOT) analytical deviations
• Provide analytical/technical support to Jazz Technical Operations and External Manufacturing
• Ensure that operations within External Manufacturing and contract testing laboratories are compliant with cGMPs and in compliance with regulatory filings.
• Lead analytical method transfers/validation programs in compliance with regulatory/Jazz requirements
• Troubleshooting of analytical methods
• Operate Jazz CAPA/deviation, training and compliance systems
• Author, Review and approval of SOPs, analytical validation protocols and reports.
• Use of Quality Systems to realize the highest quality standards attainable for all activities conducted by the company.
• Maintain Quality Control Metrics/KPIs as directed
• Product trending programs for assigned products at release and stability
• Build relationships and participate in business meetings, as required with suppliers and contract manufacturers and maintain all product-related, Quality Technical Agreements (QTA’s).
• Support the creation and maintenance of regional and global quality control and laboratory systems in relation to quality control operation.
• Actively support QC system improvements to ensure efficient, effective and compliant process
• Ensure of compendial method updates implemented as appropriate for Jazz products

Qualifications

• Bachelors of Science, Masters or equivalent in biochemistry, chemistry or a related discipline
• At least 3-5 years’ experience working in a laboratory/quality environment within the pharmaceutical industry
• Experience in Biologics/Drug product/Drug Substance/APIs is desirable
• Demonstrated knowledge of quality systems, FDA and EU guidelines as the relate to analytical testing/product manufacturing
• Experience with regulatory inspections
• Strong Interpersonal skills and professional skills to interact at all levels including senior management, contractors, and colleagues