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Knack NY · 1 week ago
Senior QA Deviation Investigator
Bothell, WA
Contract
Onsite
Senior Level
4+ years exp
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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.
Qualification
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Required
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
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.
Benefits
Professional development opportunities
Dynamic and collaborative work environment
H1B Processing (EMPLOYMENT SPONSORSHIP AVAILABLE)
Contract to PERM role
Company
Knack NY
We are a specialist Creative Branding & Digital Agency based in New York, built to design visually appealing, high-ranking websites and content for various service industries, ranging from law firms, doctors to Staffing and HR.
11-50 employees
H1B Sponsorship
Knack NY has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Trends of Total Sponsorships
2023 (6)
2022 (11)
2021 (9)
2020 (5)
Funding
Current Stage
Early StageCompany data provided by crunchbase
