Senior Staff MTO

Boston, NH - USA

Monthly Salary: $ 65 - 70

Posted on: 16 hours ago

Vacancies: 1 Vacancy

Job Summary

Application Deadline: Feb. 28 2026
Boston
On-site
Hourly salary: $65 - $70

Job Description

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.

Required Experience:

Staff IC

Application Deadline: Feb. 28 2026 BostonOn-siteHourly salary: $65 - $70Job DescriptionKEY RESPONSIBILITIES: Triage manufacturing issues in real-time on manufacturing floor. Use root cause analysis tools to lead and write investigations quality events ...