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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