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Sr. Manufacturing Technical Operations
50 Northern Avenue, Boston, MA 02210 Boston, MA 02210 US
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 one of the following 4 shifts:
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.
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Planet Pharma is an equal opportunity employer. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.
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