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Responsibilities:

• Lead investigations to adequately identify root cause and implement appropriate corrective and preventative actions to prevent recurrence by:
• Lead problem solving and root cause analysis sessions
• Interact with multiple functions including, but not limited to, QA, QC, Engineering, TS/MS, Operations, HSE
• Manage highly complex and visible investigations using different root cause methodologies such as Pareto, 5 Why's, Causal Factor Charting, Human Error Checklist, Fishbone, and Fault Tree.
• Ensure effective implementation of corrective and preventive actions
• Assess effectiveness of corrective/preventive actions implemented
• Utilize technical writing strategies to ensure content is clear, concise, and complete.
• Monitor and ensure the health of the site's Deviation Management System by participating in metrics reviews, Management Reviews, etc.
• Train, coach and mentor functional area Lead Investigators in aspects of incident/observation reporting, problem solving, and risk management associated with root cause investigations, investigation write-ups, development of CAPA and associated effectiveness checks.
• Observe activities on the manufacturing floor and laboratory; engage with Process Owners to gain the process knowledge needed to deliver technically sound investigations and action plans.
• Maintain current awareness of regulations, industry trends, and regulatory agency interpretation of GMP Deviation Management System requirements.
• Maintain and build investigation skills through ongoing training and education. Participate in inspection readiness activities and support regulatory inspections by discussing investigations as required with regulatory agencies.

Requirements:

• Bachelor's degree or higher in the sciences, engineering, or related field. Candidates with no degree and 10+ years of experience in various functions supporting GMP will also be considered.
• Strong knowledge of GMP and quality systems with a minimum of 3 years of experience in manufacturing and laboratory operations.
• Experience within the Biopharmaceutical industry is preferred.
• Excellent technical writing skills required.
• Requires strong skills related to coaching and mentoring others.
• Strong problem solving and analytical skills are required.
• Experience with a variety of root cause methodologies.
• Must have excellent organizational, verbal and written communication skills; able to efficiently communicate with cross- functional teams and management on recommended course of action, with minimal assistance.
• Possess knowledge of core manufacturing principles and support systems.
• Must have good interpersonal skills and be able to work effectively and efficiently in a team-based environment.
• Self-driven individual that requires minimal supervision.
• Proficient computer skills and be experienced using MS Office software (Word, Excel and PowerPoint), TrackWise (preferred).