We're currently recruiting for an exciting opportunity. This is an excellent position for anyone looking to join a leading multinational who are one of the best at what they do.
Investigations Leads will be primarily responsible for leading investigations into fill/finish/inspection and packaging deviations. Specialists will also be involved in applying process, quality, compliance, and analytical knowledge.
Duties:
* 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 and 5+ years of directly related experience in a biotech/pharma manufacturing or manufacturing support role (i.e. 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 (i.e. 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 and technical writing.
* Experience presenting to inspectors during regulatory inspections and internal audits.