Quality Control (Deviation investigations)

Quality Control (Deviation investigations)

Boston, MA (Fully onsite)

Schedule: Wed - Sat 9a - 7:30pm

MUST HAVES

• 6 years progressive experience in pharmaceutical development and manufacturing.
• BS in engineering, science or related discipline.
• Most important thing is a QC heavy background (OOS work, deviations, investigations, etc.).
• 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.

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.