Senior Quality Associate
3 weeks ago
Vertex Pharmaceuticals is seeking a Senior Quality Associate to join our team. As a key member of our quality assurance team, you will be responsible for ensuring the quality of our pharmaceutical products.
Key Responsibilities:
- Perform disposition activities for Finished Goods in support of Clinical/Commercial Product.
- Review and resolve comments/issues on Master and Executed Batch Records.
- Evaluate Investigations/OOS/Change Controls to support Disposition Status.
- Approve Certificate of Analysis.
- Update Status in Oracle.
- Archive batch documents in electronic document system.
- Collaborate with internal teams to review and approve procedures.
- Provide quality guidance for root-cause analysis and product impact assessment for investigations.
- Support quality oversight of artwork/label review, approval, and implementation.
- Develop relationships with external partners to support Vertex's commercial portfolio.
Requirements:
- Relevant degree.
- Good communication skills and ability to engage with internal and external stakeholders.
- Demonstrated ability to work independently to provide QA support for relevant projects.
- Skilled in creating and maintaining spreadsheets in Excel.
- Knowledge of global GMP/GDP requirements governing oral drug products.
- Knowledge of packaging and labeling process and artwork requirements.
- Investigation and Root Cause Analysis tools/methodology.
- Audit process understanding.
Flex Designation:
This role is eligible for Vertex's Flex @ Vertex Program, allowing you to choose between Hybrid or On-Site work arrangements.
Company Information:
Vertex Pharmaceuticals is a global biotechnology company committed to equal employment opportunity and non-discrimination for all employees and qualified applicants.
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