Contract QA Sr. Specialist, Deviation Investigator (Remote)

  • Permanent
  • Anywhere

Website Kelly


Company : Kelly

Country: United States

Location : Redmond, Washington

Post: Sat, 11 Sep 2021 05:02:19 GMT

Expires: Mon, 11 Oct 2021 23:59:59 GMT

Apply Job : Apply Online

—————————— Job Description ——————————

* 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:

* Demonstrates good teamwork, collaboration, and communication skills with all internal and external customers
* Seeks to understand, demonstrates humility, and shows curiosity for learning
* 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
* Understands appropriate assignment of classifications and requirements for each
* Understands the importance and impact of lot association within deviations and the relation to product disposition
* Captures the necessary data to support containment activities and impact assessment
* Attaches all necessary supporting evidence to the electronic deviation and ensures all attachments have been referenced in the record
* 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
* Utilizes good technical writing skills
* Contact vendor as needed to complete investigations in a timely manner
* May participate on deviation governance teams, projects, and other initiatives


* 7+ years of relevant cGMP experience. Experience in FDA/EMA regulation in the biotechnology and/or cellular therapy field is preferred.
* Minimum of 4 years working within quality systems managing deviation and CAPA records.
* Experience with use of complex Root Cause Analysis (RCA) tools and methodologies.
* Experience with use of complex research techniques and methodologies like six sigma and Kaizen to improve process/product quality is a plus.
* Background in Protein Biologics or Cell Therapy Manufacturing is strongly recommended.

Why Kelly?

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed. About Kelly

At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world. Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. [

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