About the job
Join our dynamic production team at AbbVie as a Production Coordinator - USP. Reporting to the USP Manager, you will play a crucial role in overseeing the large-scale production of recombinant proteins derived from mammalian cells, all while adhering to GMP standards. This position focuses on operational management, ensuring GMP compliance, and driving continuous process improvement.
This is a daytime position (not subject to a 3x8 schedule) and does not involve direct management but requires cross-functional responsibility with team leaders and support functions.
Main Responsibilities:
Operational Support and Oversight:
- Assist the USP Manager in organizing, planning, and coordinating cell culture production activities.
- Ensure operations align with production schedules and GMP requirements.
Quality Support Management:
- Manage or support deviations and CAPA (opening deviations, Booster meetings, participation in assessments, handling deviations, implementing and tracking service CAPA).
- Change Control: Initiate and vet CCPs, approve and monitor associated actions.
- Inspection readiness: Participate in audit preparation, track action plans, and manage workshop readiness.
EHS (Environment, Hygiene, Safety):
- Actively participate in EHS inspections and implement corrective actions.
- Contribute to the site’s safety culture and maintain a safe and compliant working environment.
Process Transfer and Technical Documentation Management:
- Engage in process transfer activities. Validate MBRs and production recipes.
- Coordinate between MSAT and production teams to integrate new processes.
Cell Culture Operations Management:
- Collaborate with support functions (Quality, Engineering, Logistics, Planning).
- Actively participate in operational preparation (monitor BOM/POP needs, define level III planning framework).
Post-Production and Continuous Improvement:
- Audit and review batch records post-production.
- Monitor corrections and improvement actions.
- Contribute to specific departmental projects.
- Lead or contribute to continuous improvement initiatives focused on performance, quality, and safety.
Backup Responsibilities:
- Provide operational backup for the manager in their absence.
- Support operational teams with technical and scientific assistance.
- Oversee and coordinate activities related to the development of cell culture operations.