Deviation Investigator - Bothell, United States - TSR Consulting Services, Inc.

Description

TSR is a premier National U.S. Staffing company with over 50 years of staffing excellence.

Our client, a leading pharmaceutical company is hiring a Deviation Investigator on a contract basis. Please only local candidates to Bothell WA. Relevant cGMP experience is a must.

Work Location: Bothell WA

Pay: $62-63/hour W2

Required Skills:

• Responsible for overseeing and supporting the management of deviation records through the electronic quality record management system
• Responsible for investigating No Impact, Minor, Major, and Critical deviations to determine root cause, corrective actions, ensuring the written report contains the technical merit and completeness according to regulatory expectations
• This position will be responsible for operating cross-functionally, collecting necessary data and information associated with the manufacturing and laboratory investigations and determine the associated corrective action to prevent the deviation from reoccurring
• This person will be a key player and a champion for quality priority principles and compliance
• Experience in FDA/EMA regulation in the biotechnology and/or cellular therapy field is preferred
• Experience working within quality systems managing deviation and CAPA records
• Experience authoring deviation and CAPA records
• Expertise in GMP compliance and FDA/EMA regulations
• 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
• Owns and investigates department-specific trend deviations
• Leads investigation team to perform deep-dive analysis of department-specific trends
• 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