Specialist - Manufacturing Investigations

• 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
• Coordinate 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

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

• 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

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans and bi-annual company-wide shutdowns
• Flexible work models, including remote work arrangements, where possible