Deviation Investigator

Responsibilities :

• 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.
• Ability to anticipate and mitigate challenges.
• Actively 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.

Requirements :

• Minimum of Bachelor's degree in relevant Science or Engineering discipline and / or equivalent combination of work experience is required.
• years of relevant cGMP experience. Experience in FDA / EMA regulation in the biotechnology and / or cellular therapy field is preferred.
• Minimum of years working within quality systems managing deviation and CAPA records.
• Experience authoring deviation and CAPA records
• Demonstrated proficiency in selection of team and effectively managing personnel issues is highly desired. Proven ability to demonstrate attention to detail, personal and team accountability where it is critical to success.
• Owns and investigates department-specific trend deviations. Leads investigation team to perform deep-dive analysis of department-specific trends, including to.
• Assess 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.
• Applies 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.
• Attaches 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.
30+ days ago