Senior QA Deviation Investigator

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 apply with your updated resume.