[Apply in 3 Minutes] Manufacturing Specialist
14 hours ago
Manufacturing Specialist - Investigation Lead
RK3800
Manufacturing Specialist (Investigation Lead)
12 month contract
Biopharmaceutical manufacturing
Hybrid
Description:
The Manufacturing Specialist (Investigation Lead) will be primarily responsible for leading investigations for fill/finish/inspection and packaging deviations. Specialists will also be involved in applying process, quality, compliance, and analytical knowledge to complete the following:
- Manage deviation investigations, including establishing investigation teams, leading root cause analysis, development of CAPAs, completing product impact assessments, and writing comprehensive compliant documentation of all findings.
- Clear and concise technical writing of complex investigations.
- Drive improvements to the investigation process.
- Present investigations to regulatory inspectors and internal auditors.
- Clearly communicate investigation progress to impacted areas and leadership.
- Coordinate and lead cross-functional teams through complex investigations, and complete tasks on-schedule.
- Project management of the investigations end to end.
- Present complex topics to large and small groups at various levels and quickly understand and clearly communicate complex issues.
- Build effective relationships across functions.
- Navigate through ambiguity and provide a structured problem-solving approach.
- Able to apply inductive and deductive reasoning in the investigation process.
Education and Experience:
- Bachelor's Degree in Science or Engineering.
- 5+ years of directly related experience in a biotech/pharma manufacturing industry.
- Experience with compliance, problem-solving, root cause analysis, critical thinking, project management, leading complex investigations, and quality systems.
- Detailed technical understanding of fill/finish operations.
If you are interested in this posting, please feel free to contact Rachel Kent at Life Science Recruitment for further information.
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