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Senior Quality Specialist
at Vertex
Boston, MA

Senior Quality Specialist
at Vertex
Boston, MA

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Description

Job Description:

The Senior Quality Specialist works with a high degree of independence and is adept at troubleshooting problems to create and execute improved internal procedures, and to ensure compliance with applicable regulatory requirements. Senior Quality Assurance Specialist in the CMC and Patient Safety department is responsible for supporting review activities associated with analytical data and manufacturing documents in support of release, stability, investigations, regulatory filing for development products. The scope includes drug substance, sprays dried dispersion, drug product and packaged finished goods. The ideal candidate will possess a strong knowledge of GMP manufacturing regulations, laboratory data analysis and excellent written and verbal communication skills.

This position reports to Associate Director.

Key Responsibilities:

  • Review and approval of analytical data, manufacturing batch records, item codes, COAs, protocols, analytical data, summary reports for drug substance, spray dried dispersion, bulk drug product for Clinical product.
  • Approves deviations, investigations/CAPAs as assigned
  • Review all completed analytical data and manufacturing records for compliance and accuracy
  • Assist with regulatory agency inspections as required

Qualification:

  • M.S (or equivalent degree) and 0-3 years of relevant work experience, or
  • B.S in scientific or allied health field (or equivalent degree) and 5-8 years of relevant work experience
  • Demonstrates expertise related to understanding the principles and application of Quality and Regulatory compliance
  • Maintains a contemporary knowledge of current industry trends, standards and methodologies as it relates to GMP quality systems and practices

    *
  • Operational QA experience- in analytical or manufacturing setting with emphasis on Batch record review, analytical data review and deviation review.
  • Experience with Change control, inventory management systems such as OPM and Quality System background helpful.
  • Demonstrates ability to effectively communicate and influence the outcomes of the decision making process.

  • Proven ability to manage projects, while meeting all deliverables and timelines

  • Establishes/maintains effective cross functional team communications to advance quality activities of Vertex

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