Senior MTO

Position: Senior Staff MTO
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.

Manufacturing
Deviations
CAPA
Change Control
Investigations
Root Cause Analysis (RCA)