Quality Assurance Operational Specialist (Contract) 26660

The QA Operations Specialist, is responsible for the quality compliance oversight and data review of analytical method activities associated with method lifecycle management, critical reagent qualification, assay trending, stability as well as quality events which may occur during release and stability testing of Cell & Genetic Therapy products.  This role requires collaborative interaction with cross-functional partners to ensure critical product development milestones are met as well to ensure the compliant on-time closure of deviations, analytical investigations, CA/PA, and change controls.

The role will closely partner with Quality Control, Analytical/Process Development and Manufacturing stakeholders to meet business, regulatory and operational requirements. This role will support analytical method lifecycle activities, including method qualification, transfer, verification, and validation.

Key Duties & Responsibilities

• Proactively maintain Quality Assurance oversight of Quality Control associated quality events, including but not limited to OOS investigations
• Responsible for the QA oversight of the trending and tracking of QC Quality Control associated quality events, to assure compliance with internal Vertex procedures and EU/US regulatory standards.
• Ensure compliance with phase appropriate cGMPs.
• Support the verification of investigation reports for deviations, out of specifications, risk assessments and root cause analyses
• Lead/participate in the development of Vertex global Quality system standards and SOPs.
• Review and approve relevant documentation (assay packets, LIMS master data, LES data), protocols and reports associated with analytical lifecycle initiatives, including deviation investigations and change control.
• Support review and data verification of relevant sections of regulatory submissions including IND’s as assigned; Assist in responses to regulatory questions where applicable.
• Responsible for identifying compliance risks and gaps, and associated execution for the implementation of mitigating controls.
• Support contract test labs management process including the creation and review of Quality Agreements
• Lead/ participate in Cell & Genetic Program Quality & technical projects and drive continuous improvement activities as assigned by Management.  Ensure activities and deliverables are in compliance with FDA, EMA, SOPs and industry best practices

Required Education Level

• Bachelor's degree in an engineering/Lifesciences field.
• Master's degree or relevant comparable background.

Required Knowledge/Skills

• In-depth global regulatory agency knowledge and experience across GXP life cycle in Cell & Gene therapy and/or Biologics, broad knowledge of ICH Guidelines, EU/FDA regulations.
• Experience in method development for cellular programs, clinical product development and analytical method development
• Broad understanding of regulatory environment including quality systems, compliance and strategy for Cell & gene technology
• Ability to lead improvement projects - experience with Root Cause Analysis, data analytics, and other Operational Excellence experience, such as LEAN, DMAIC, Six Sigma.
• Excellent communication skills and a proven track record Influencing/building/promoting a culture of Quality and Excellence.
• Ability to apply risk management principles to decision making and operational priorities.
• Critical Thinker and Problem Solver
• Strong influencing skills and an innate ability to collaborate and build relationships
• Typically requires 3-5 years of relevant industry experience in a regulated environment, primarily in Quality Assurance, or other technical roles such as manufacturing operations or quality control in biotechnology/regulated pharmaceutical environment

$45-$55/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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