Deviation Investigator - Bothell, United States - Cynet Systems

Description

• ctively manages deviations to achieve RFT (right first time) and on-time phase completion, including deviation closure by the original due date.
• Immediately upon assignment of an investigation, partners with their investigation team (QA Reviewer/ Approver, SMEs [subject matter experts], and necessary stakeholders) on definition and alignment of the investigation plan, required data, and timing for completion.
• Continues to partner with investigation team throughout the investigation process to ensure agreement / alignment on root cause and CAPA.
• When CAPA are needed, facilitates the investigation / CAPA team to define objectives, deliverables, ownership, due dates, and effectiveness requirements.
• Ensures smooth transition of the defined CAPA to the owning department SME and ensures the CAPA progresses to implementation timely to ensure on-time deviation closure.
• Owns and investigates department-specific trend deviations.
• Leads investigation team to perform deep-dive analysis of department-specific trends, including to.
• ssess trend details to ensure accuracy and alignment across the team.
• Facilitate in-depth root cause analysis to determine additional process and system failure modes.
• Evaluate previous root causes and CAPA (in-progress or implemented) identified to lessen the trend.
• Determine if previous identified CAPA are sufficient to reduce the trend by defined targets.
• Leads GEMBAs and interviews the people closest to the work to identify failure modes and seek further understanding of the deviations.
• pplies HOP (Human and Organizational Performance) principles to investigations.
• Uses both soft-skills and technical skills to drive the deviation and CAPA processes.
• Demonstrates good teamwork, collaboration, and communication skills with all internal and external customers.
• Seeks to understand, demonstrates humility, and shows curiosity for learning.
• Completes deviations that are thorough, accurate, and complete.
• Understands the overall deviation and CAPA processes including all phases of the records and proper content for each phase.
• Understands appropriate assignment of classifications and requirements for each.
• Understands the importance and impact of lot association within deviations and the relation to product disposition.
• Captures the necessary data to support containment activities and impact assessment.
• ttaches all necessary supporting evidence to the electronic deviation and ensures all attachments have been referenced in the record.
• Performs investigations and root cause analyses that are commensurate to the event being investigated.
• Understands multiple RCA tools and when, where, and how to apply them.
• Utilizes good technical writing skills.
• Contacts vendor as needed to complete investigations in a timely manner.
• May participate on deviation governance teams, projects, and other initiatives.

• Expertise in GMP compliance and FDA/EMA regulations.
• Demonstrate excellence in written and verbal communication.
• Demonstrated ability to work cross-functionally and to develop and maintain strong business partner relationships.
• Innovative, proactive, and resourceful; committed to quality and continuous improvement.
• bility to anticipate and mitigate challenges.