We are #hiring for Senior QA Deviation Investigator, please review the Job Description below:
We are #hiring for below position: Position: Senior QA Deviation Investigator Location: (Bothell, WA) - 100% Onsite Qualifications: · Minimum of Bachelor’s degree in relevant Science or Engineering discipline and/or equivalent combination of work experience is required. · 4+ years of relevant cGMP experience. Experience in FDA/EMA regulation in the biotechnology and/or cellular therapy field is preferred. · Minimum of 2 years working within quality systems managing deviation and CAPA records. · Experience authoring deviation and CAPA records Skills: · 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. Key Responsibilities: · Actively manages deviations to achieve RFT (right first time) and on-time phase completion, including deviation closure by the original due date. · 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. · 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. · 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. · 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. Benefits: · Professional development opportunities · Dynamic and collaborative work environment · H1B Processing (EMPLOYMENT SPONSORSHIP AVAILABLE) · Contract to PERM role Candidate MUST BE Authorized to work in the United States OPT / STEM OPT / H1 / H4 EAD / GC / USC all welcomed to apply We won't work on C2C for GC and USC If you meet the qualifications and are interested, please DM your updated resume.