QE Execution Staff, Manufacturing Technical Operations (contract) 804 Vertex Pharmaceuticals

• 3.7 Boston, MA Job Details Full-time $34
• $67 an hour 5 hours ago Qualifications Project management experience in manufacturing Pharmaceutical company experience Managing projects Pharmaceutical manufacturing facility experience

Full Job Description Job Description:

This staff member on the MTO is responsible for ownership and execution of quality records including, Deviations, CAPAs, Change Controls, and Analytical and Quality Control Investigations supporting cell manufacturing at our Boston site. This includes all aspects of QE execution including data review, interviews, root cause analysis, GEMBA, project management, excellent collaboration, and communication. This execution-focused role will follow the MTO Engineering Operations ways of working, and QA aligned best-practices to efficiently and effectively execute records through completion. This role is an on-site position based in our Boston and has a defined shift depending on the hiring manager.

• The ideal candidate will have experience with investigations, root cause analysis, technical writing, validation and deviation triaging

•

Shifts:

Sunday-Thursday:

8:00am

• 4:30pm Tuesday

• Saturday:

  8:00am
• 4:30pm

KEY RESPONSIBILITIES

Involved in deviation triage including coordination and investigational planning and event initiation Identify and collaborate with SMEs for triage, determine immediate actions and containment, and document initial impact assessments. Lead investigation for manufacturing, QC, material, facility and equipment deviations including interviews, GEMBA using root cause analysis tools Use root cause analysis tools to lead and write quality events in cell manufacturing, quality control, material operations and facility operations functional areas. Collaborate with subject matter experts on investigations to determine root cause and propose appropriate corrective and preventive actions. Own, drive and manage CMC CAPAs and change controls from initiation, assessment and planning, execution, and closure. Actively own and drive QE records (deviations, CAPA, Effectiveness Check, change control) in electronic Quality Management System (eQMS). Ensure all timelines and due dates are achieved. Promote MTO and QA

• aligned compliance best practices established by MTO and QA leadership.

Tracking of deliverables and timely escalations in MTO project management tool (Smartsheet) Other duties and projects as assigned to meet departmental requirements and manufacturing timelines.

QUALIFICATIONS

Senior Level:

Any Degree with 5+ years engineer, project management, pharmaceutical experience

• Experienced in fast-paced environment Mid-Leve l: Engineering or Relevant Degree with 2-5 years' work experience
• Some experience in industry desired

Junior Level :

Engineering Degree with 0-1 year experience

• Eager to learn about the industry

Pay Range:

Jr:

$34

• 38/hr

Mid:

$48

• 53/hr

Sr:

$63

• 67/hr

Requisition Disclaimer:

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 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 (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 . 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 . Please include the job title in the subject of your email. No C2C or Third-Party Vendors