Purpose
The Manufacturing Specialist (Investigation Lead) is a 12-month hybrid position primarily responsible for leading investigations into fill/finish/inspection and packaging deviations.
Responsibilities
* Manage deviation investigations, including establishing investigation teams, leading root cause analysis, developing CAPAs, completing product impact assessments, and writing comprehensive compliant documentation of all findings.
* Drive improvements to the investigation process.
* Presentation of investigations to regulatory inspectors and internal auditors.
* Clear communication of investigation progress to impacted areas and leadership.
* Coordination and leadership of cross-functional teams through complex investigations, and completion of tasks on-schedule.
Project Management
End-to-end project management of investigations.
Communication Skills
* Presentation of complex topics to large and small groups at various levels.
* Clear understanding and communication of complex issues.
* Building effective relationships across functions.
Problem-Solving
* Navigating ambiguity with a structured problem-solving approach.
* Application of inductive and deductive reasoning in the investigation process.
Qualifications
Bachelor's Degree in Science or Engineering and 5+ years of directly related experience in biotech/pharma manufacturing or manufacturing support role.
OR Associate's Degree in Science or Engineering and 8+ years of directly related experience in biotech/pharma manufacturing or manufacturing support role.
10+ years directly related experience in 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.
Participation in and leadership of cross-functional teams.
Management of multiple competing priorities in fast-paced environment.
Presentation to inspectors during regulatory inspections and internal audits.
Excellent technical writing.
Excellent presentation and communication skills.