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
Qualifications
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 environment
Detailed technical understanding of fill/finish operations
Experience with compliance, problem-solving, root cause analysis, critical thinking, project management, and quality systems.
Experience leading complex investigations
Experience participating in and leading cross-functional teams
Experience in managing multiple, competing priorities in a fast-paced environment
Experience presenting to inspectors during regulatory inspections and internal audits.
Excellent technical writing
Excellent presentation and communication skills, ability to communicate and collaborate with technical and management staff
Ability to be flexible and manage change
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