Senior Specialist, Manufacturing Technical Operations (Contract) 28190

This Senior Specialist in Manufacturing Technical Operations (MTO) is responsible for complete ownership of quality records including, but not limited to Deviations, Analytical Investigations, CAPAs, Change Controls, and Risk Assessments supporting cell manufacturing at our Boston site. The person in this role will drive cross-functional root cause analysis meetings and promote compliance best-practices to ensure timely and thorough completion and will focus on deviations. This includes all aspects of MTOs operational compliance support with emphasis on tracking and executing CGT initiatives, implementing MTO best practices and ensuring exceptional internal and external department collaboration and communication. This role will be pivotal for distributing and acting on metrics as well as supporting MTO intake and prioritization. This role is an on-site position based in our Boston location. This role requires a high-level of schedule flexibility to support our cell manufacturing clinical hours of operation and timelines. KEY

RESPONSIBILITIES:

• Lead, write and reviewdeviations and investigations for Vertex Cell and Genetic Therapies (VCGT). Including the manufacturing, facilities, supply chain/materials management and support QC deviations.
• Identify and assemble proper SMEs for triage, determine immediate actions taken, document impact assessments, lead RCA, develop appropriate CAPAs.
• Coordinate meetings with SMEs for triage, determine immediate actions taken, document impact assessments, perform RCA, develop appropriate CAPAs.
• Own deviation, CAPA and Effectiveness Check (EC) records in electronic Quality Management System (eQMS) and drive to completion by record due dates.
• Apply GMP concepts and internally aligned interpretations of regulatory guidance to ensure consistent and compliant practices across VCGT.
• Collaborates with subject matter experts to develop controlled documentation, ensuring accuracy and completeness, and provides ongoing support to facilitate effective implementation.
• Demonstrate Vertex behaviors: Lead by Example; Learn, Teach & Develop; Foster Exceptional Collaboration; Drive Breakthrough Results; and Promote Enterprise Thinking.
• Other duties and projects as assigned to meet departmental requirements. REQUIRED KNOWLEDGE AND SKILLSKnowledge of cGMP requirements

REQUIRED KNOWLEDGE AND SKILLS:

• Knowledge of cGMP requirements
• Strong organizational skills
• Adept in managing multiple regulated records in parallel
• Strong interpersonal skills, including the demonstrated ability to manage through influence and lead dynamic teams
• Experience with technical writing including the creation of procedures, reports, and training materials
• Experience using quality management software to manage quality documentation and records in a regulated environment

EDUCTION AND EXPERIENCE

• Minimum 5 years working experience in relevant field (may be reduced based on education level).
  
  

$65-$69/hr

This job posting is for a temporary role with a third-party agency partner on assignment at Vertex Pharmaceuticals (“Vertex”). The individual selected for this role will be offered the role as an employee of a third- party agency partner; compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by the third-party agency partner upon offer. The pay rate range provided is a reasonable estimate of the anticipated compensation range for this job at the time of posting. The actual pay rate will be based on a number of factors, including skills, competencies, experience, location and/or being pursued and other job-related factors permitted by law. In addition, this role will be eligible for overtime pay, in accordance with federal and state requirements

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