LinkedIn and 3rd parties use essential and non-essential cookies to provide, secure, analyze and improve our Services, and to show you relevant ads (including professional and job ads) on and off LinkedIn. Learn more in our Cookie Policy.
Select Accept to consent or Reject to decline non-essential cookies for this use. You can update your choices at any time in your settings.
This range is provided by Knack NY. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range
$40.00/hr - $50.00/hr
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.