Senior Specialist, Manufacturing Technical Operations (Contract) 28190

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    "description": "<h2>Job Description</h2>\n<p>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</p>\n<p> </p>\n<p><strong>RESPONSIBILITIES</strong>:</p>\n<p> </p>\n<ul>\n <li><strong>Lead, write and review</strong> <strong>deviations and investigations</strong> for Vertex Cell and Genetic Therapies (VCGT). Including the manufacturing, facilities, supply chain/materials management and support QC deviations.</li>\n <li>Identify and assemble proper SMEs for triage, determine immediate actions taken, document impact assessments, lead RCA, develop appropriate CAPAs.</li>\n <li>Coordinate meetings with SMEs for triage, determine immediate actions taken, document impact assessments, perform RCA, develop appropriate CAPAs.</li>\n <li>Own deviation, CAPA and Effectiveness Check (EC) records in electronic Quality Management System (eQMS) and drive to completion by record due dates.</li>\n <li>Apply GMP concepts and internally aligned interpretations of regulatory guidance to ensure consistent and compliant practices across VCGT.</li>\n <li>Collaborates with subject matter experts to develop controlled documentation, ensuring accuracy and completeness, and provides ongoing support to facilitate effective implementation.</li>\n <li>Demonstrate Vertex behaviors: Lead by Example; Learn, Teach & Develop; Foster Exceptional Collaboration; Drive Breakthrough Results; and Promote Enterprise Thinking.</li>\n <li>Other duties and projects as assigned to meet departmental requirements. REQUIRED KNOWLEDGE AND SKILLSKnowledge of cGMP requirements</li>\n</ul>\n<p><strong>REQUIRED KNOWLEDGE AND SKILLS</strong>:</p>\n<p> </p>\n<ul>\n <li>Knowledge of cGMP requirements</li>\n <li>Strong organizational skills</li>\n <li>Adept in managing multiple regulated records in parallel</li>\n <li>Strong interpersonal skills, including the demonstrated ability to manage through influence and lead dynamic teams</li>\n <li>Experience with technical writing including the creation of procedures, reports, and training materials</li>\n <li>Experience using quality management software to manage quality documentation and records in a regulated environment</li>\n</ul>\n<p> </p>\n<p><strong>EDUCTION AND EXPERIENCE</strong></p>\n<p> </p>\n<ul>\n <li>Minimum 5 years working experience in relevant field (may be reduced based on education level).</li>\n</ul>\n<h2>Pay Range</h2>\n<p><strong>$65-$69/hr</strong></p>\n<h2>Requisition Disclaimer</h2>\n<p>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</p>\n<p> </p>\n<p>By applying for this position, you agree to the Atrium Terms and Conditions and you direct Atrium to share your application materials, which may include your CV/Resume, email address or phone number, with Vertex. For more information on how Vertex handles your personal data related to your job application, please see Vertex’s Careers Privacy Notice.   Agreeing to the Atrium Terms and Conditions, includes permission to use the email address and mobile phone number you provide during the application process or throughout the duration of your prospective or actual employment to notify you of job openings, profiles, articles, news, and other employment-related information, as well as to notify you of special promotions or additional products and services offered by us or our affiliates and partners</p>\n<p>(collectively, “Atrium Alerts”). Atrium Alerts may be sent by email, phone, or text message. Your personal information will be safely stored within the Atrium & Vertex databases. Atrium does not sell your personal information to third parties. Text message and data rates may apply. To OPT OUT of text messaging or to modify your communication preferences for Atrium Alerts at any time, please contact Atrium at [email protected].</p>\n<p> </p>\n<p>If you do not agree with the Atrium Terms and Conditions, you can still complete your application for this position by emailing your resume to our team at [email protected]. Please include the job title in the subject of your email.</p>\n<p> </p>\n<p><strong>No C2C or Third-Party Vendors</strong></p> ",
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