Senior Manufacturing Operations Technician (Contract)

Vertex; Boston (MA); On-site; USD 125,000 - 150,000; Full time

Job summary

A leading company in the pharmaceutical industry seeks a senior-level staff member for complete ownership of quality records at their Boston site. This role involves triaging manufacturing issues, collaborating with experts, and driving compliance best practices. The ideal candidate will have over 6 years of experience in pharmaceutical development, excellent planning skills, and a strong background in technical writing within a GMP-compliant environment. The position offers competitive pay and the opportunity for extension after 12 months.

Qualifications

• 6+ years experience in pharmaceutical development and manufacturing.
• Excellent planning and organizational skills.
• Experienced with technical writing and performing event investigations.

Responsibilities

• Triage manufacturing issues in real-time on the manufacturing floor.
• Lead and write investigations on quality events.
• Own deviations, CAPA, and change controls in eQMS.

Skills

Planning

Organizational skills

Technical writing

Event investigations

Education

BS in engineering

BS in science

BS in related discipline

Job description

Job Description

This senior-level staff member on the MTO is responsible for complete ownership of quality records including, but not limited to Deviations, CAPAs, Change Controls, Risk Assessments and Analytical and Quality Control Investigations supporting cell manufacturing at our Boston site. This includes all aspects of record ownership, triages, investigation, CAPA and change controls. The person in this role will drive cross-functional root cause analysis meetings and promote compliance best-practices to ensure timely and thorough completion. 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. This senior-staff members work the following shifts

Wednesday – Sunday 9a-7:30p

This is a 12 month contract with chance to extend.

KEY RESPONSIBILITIES:

• Triage manufacturing issues in real-time on manufacturing floor.
• Use root cause analysis tools to lead and write investigations quality events in the cell manufacturing, quality control, material operations and facility operations functional areas.
• Identify and collaborate with SMEs for triage, determine immediate actions and containment, document initial impact assessments.
• 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.
• Own deviations, CAPA, Effectiveness Check (EC) and Risk Assessment records in electronic Quality Management System (eQMS). Ensure all timelines and due dates are achieved.
• Promote MTO and QA- aligned compliance best practices to further establish operational and quality event record center of excellence teams.
• Other duties and projects as assigned to meet departmental requirements and clinical timelines.

QUALIFICATIONS:

• 6+ years progressive experience in pharmaceutical development and manufacturing.
• BS in engineering, science or related discipline.
• Excellent planning and organizational skills, with the ability to balance production, development and continuous improvement needs.
• Experienced with technical writing and performing event investigations in a GMP-compliant environment.
• Experience gowning manufacturing floor in Grade B environments.

Pay Range

$60-$70/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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