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Job Description

GENERAL POSITION SUMMARY:

The Specialist, Manufacturing Technical Services will work collaboratively across departments, as part of the Manufacturing Technical Investigations & Analytics (MTIA) team, to ensure a state of compliance exists within Vertex Manufacturing Center (VMC), manufacturing, facilities, and warehouse operations. This position will facilitate improvements to documentation, procedures, and processes that will enhance efficiency and ensure best practices are implemented. This position will also work with senior personnel on continuous improvement and site efficiency projects. The Specialist, Manufacturing Technical Services reports directly to the Sr. Manager, MTIA.

KEY RESPONSIBILITIES:

• Lead root cause investigations for deviations in the Quality Management System (QMS).
• Develop corrective action plans and other relevant documents to resolve deviations.
• Assist MTS Director and MTIA team manager with management tasks, including process data analysis, providing site metrics, and preparation of meeting presentations.
• Provide project management and leadership of process related engineering projects at the VMC, including providing direction and guidance to cross-functional resources working on these projects.
• Author and submit revisions to controlled documents in support of GMP Operations, including SOPs, WIs and Master Batch records (MBRs).
• Perform Process Analytical Technology (PAT) Operator tasks during GMP manufacture.
• Apply GMP concepts and internally aligned interpretations of regulatory guidance to ensure consistent and compliant practices across GMP Operations.

TECHNICAL AND COMMUNICATIVE SKILLS AND EXPERIENCE:

• Bachelor’s Degree in a pharmaceutical science or engineering discipline, preferably chemical or mechanical engineering
• 2+ years’ experience in a GMP manufacturing facility
• Demonstrate good oral and written communication skills

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