Manufacturing Specialist - Investigation LeadRK3800
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.
#J-18808-Ljbffr