Job description
JOB DESCRIPTION
Manage, and implement the Contamination Control Programs, incl. Microbial Control strategy, working in collaboration with enterprise partners in Engineering and Quality. Ideal candidate should develop a robust physical, chemical, and microbial control strategy and / or support investigation related to such contaminations.
- Lead cross-site and cross-functional teams through complex issues and challenges.
- Provide coaching and mentoring to contamination investigation teams.
- Critically analyze data to recommend opportunities for robustness improvements.
- Facilitate, lead and / or participate on risk assessments and contamination investigations. Implement endorsed projects to drive to desired future state (where applicable use of quality system workflows change control, CAPA, Quality Improvement Plan may be employed).
- Partner with training team and / or relevant SMEs to develop and communicate best practices across Manufacturing sites.
- Own and / or support any site investigations related to physical, chemical, and microbial contaminations.
- Provide expertise to microbial related investigations.
- Ensure well written investigation reports.
- Support new product transfers as the contamination control expert.
- Support new process design for microbial control.
- Support new equipment design for microbial control.
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