Investigator, Logistics

Essential Duties And Responsibilities

• Identifies issues and can independently assess the need for non-conformance and formulate recommended containment actions in conjunction with operational leadership.
• Manage investigations in an effort for timely completion, updating procedures and assistance with training support for correction of errors as required.
• Support site departments with investigations, complaints, process improvement and training for NCRS and complaints as well as the subsequent Corrective and Preventive Actions (CAPAs).
• Cover investigations that identify robust root cause by effectively applying root cause analysis tools across a variety of non-conformance and/or complaint types.
• Observe processes on shop floor, warehouse, and central support functions (Quality Control, Receiving, Distribution) to ensure investigations are objective and detailed.
• Author investigation reports in QualityOne (QMS) utilizing strong organizational and technical writing skills with demonstrated attention to detail.
• Support department leadership with training improvements to prevent reoccurring process issues.
• Work with Quality Systems group to develop process and best practices for managing the GMP training program.
• Proactively identify and facilitate resolution of potential risks.
• Collaborate with subject-matter experts (SME) to ensure specialized subjects are appropriately addressed.
• Generate innovative ideas for content and workflow solutions with SME.
• Cookinate internal meetings/training with Supervisors and impacted areas.
• Must be flexible to meet the needs to the organization when required (competing due dates and customer prioritization).
• Analyze information required for the development or update of policy, procedure and form documentation.
• Willingness to take on new challenges and build on current skills.
• Achieve expected key performance measures.