Pharmaceutical Manufacturing and Compliance Specialist

2 weeks ago

Boston, United States Vertex Pharmaceuticals Full time

Job Description:

General Summary:

The Specialist, Manufacturing Technical Investigations and Analytics (MTIA) will work collaboratively across departments 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. The Specialist, MTIA reports directly to the Sr. Manager, MTIA.

Key Duties and Responsibilities:

  • Lead root cause investigations for deviations in the Quality Management System (QMS).

  • Develop corrective action plans and other relevant documents to resolve deviations

  • Author and submit revisions to controlled documents in support of GMP Operations, including SOPs, WIs and Master Batch records (MBRs)

  • Review executed MBRs to ensure compliance with good documentation practices (GDP)

  • Performs Process Analytical Technology (PAT) Operator tasks during GMP manufacture

  • Review PAT data obtained during GMP manufacture to support product disposition

  • Supporting the development and validation of automated data reporting related to continuous manufacturing

  • Apply GMP concepts and internally aligned interpretations of regulatory guidance to ensure consistent and compliant practices across GMP Operations.

  • Assist team manager with project management tasks, including data analysis, preparation of team presentations, collection and summary of meeting notes

Knowledge and Skills:

  • Experience with clinical, commercial and/or Solid Oral Dosage manufacturing

  • Demonstrate good communication skills both oral and written

Education and Experience:

  • Bachelors Degree in a pharmaceutical science or engineering discipline, preferably chemical or mechanical engineering

  • Typically 1+ years experience in a GMP manufacturing facility



Pay Range:

$27 - $32/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

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No C2C or Third-Party Vendors

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