The Snr Associate Manufacturing (Investigation Lead) will be primarily responsible for leading investigations for fill/finish/inspection and packaging deviations. Deviation leads 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 investigationsDrive improvements to the investigation processPresent investigations to regulatory inspectors and internal auditorsClearly communicate investigation progress to impacted areas and leadershipCoordinate and lead cross-functional teams through complex investigations, and complete tasks on-schedule.Project management of the investigations end to endPresent 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 processQualifications:Bachelor's Degree in Science or Engineering and 5+ years of directly related experience in a biotech/pharma manufacturing or manufacturing support role (ie process development, engineering, quality) OR Associate's Degree in Science or Engineering and 8+ years of directly related experience in a biotech/pharma manufacturing or manufacturing support role (ie process development, engineering, quality) * 10+ years directly related experience in a biotech/pharma manufacturing or manufacturing environmentDetailed technical understanding of fill/finish operationsExperience with compliance, problem‑solving, root cause analysis, critical thinking, project management, and quality systems.Experience leading complex investigationsExperience participating in and leading cross‑functional teamsExperience in managing multiple, competing priorities in a fast‑paced environmentExperience presenting to inspectors during regulatory inspections and internal audits.Excellent technical writingExcellent presentation and communication skills, ability to communicate and collaborate with technical and management staffAbility to be flexible and manage change
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