Specialist - Manufacturing Investigations

What you will do

• Manage Major deviation investigations, including assembling investigation teams, leading root cause analysis, development of CAPAs, and compliant documentation of all findings.
• Drive improvements to the investigation process.
• Present investigations to regulatory inspectors, internal auditors, and management.
• Clearly communicate investigation progress to impacted areas and leadership.
• Cookordinate and effectively lead cross-functional teams through complex investigations, and complete milestones on-schedule.
• 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.
• Apply inductive and deductive reasoning in the investigation process
• Clear and concise technical writing
• Use Operational Learning Team strategies to promote open collaboration with staff to maximize investigation findings.
• Develop tracking tools to ensure on-time closure and proactive review of deviation investigations.

Basic Qualifications

• Doctorate degree OR
• Masters degree in chemistry, biology, or engineering and 3 years of biotechnology operations experience OR
• Bachelor's degree and 5 years of biotechnology operations experience OR
• Associates degree and 10 years of biotechnology operations experience OR
• High school diploma/GED and 12 years of biotechnology operations experience

Preferred Qualifications

• 5+ years related work experience (manufacturing, process development, or quality assurance) in biotech or pharmaceutical industry with progressively increasing responsibility
• Experience with compliance, problem-solving, simple and complex root cause analysis tools (5-whys, fishbone, Kepner Tregoe Problem Analysis, Design of Experiment etc.), critical thinking, project management, and quality systems
• Degree in Science or Engineering
• Experience leading complex investigations
• Experience using Veeva QMS for Deviation investigations and CAPAs
• Demonstrated project management ability
• Experience presenting to inspectors during regulatory inspections and internal audits
• Excellent written and verbal communication skills
• Ability to work in a team matrix environment and build relationships with partners
• Strong interpersonal skills