Sr. Specialist, Quality Deviation Investigator

Bothell, WA 00000

Job Category: Information Technology Job Number: 140353

Job Description

Job Title:               Sr. Specialist, Quality Deviation Investigator

Location:               Bothell, Washington, US

Job Type:               Contract

Duration:               0-6 Months

Job Description:   

  • We are seeking a Sr. Specialist, Quality Deviation Investigator.  This role is responsible for leading deviation investigations to ensure the written investigation report contains the technical merit and completeness according to regulatory expectations.
  • This position will be responsible for operating cross-functionally, collecting necessary data and information associated with the manufacturing and laboratory deviations. 
  • This position will lead root cause analysis sessions with site SME’s and determine the associated corrective action to prevent the deviation from recurring.
  • This person will be a key player in the Client Quality Assurance team and a champion for quality priority principles and compliance within the Client organization. 
  • This position reports directly to the Quality Manager responsible for deviation investigation management.

Basic Qualifications And Education Requirements:

  • BS in relevant Science or Engineering discipline and 7+ years of experience in execution of deviation investigations.
  • Experience in Quality Assurance function or technical Manufacturing Science and Technology (MSAT) role in a GMP manufacturing operation.
  • GMP compliance and FDA/EMA regulations experience

Preferred Qualifications:

  • MS Degree in Science or Engineering
  • Background in Protein Biologics or Cell Therapy Manufacturing is required
  • Demonstrated excellence in written and verbal communication
  • Demonstrated ability to work cross-functionally and to develop and maintain strong business partner relationships

About ASK: ASK Staffing is an award-winning technology and professional services recruiting firm servicing Fortune 500 organizations nationally. With 5 nationwide offices, twglobal delivery centers, and employees in 42 states-ASK Staffing connects people with amazing opportunities

Reach Out TA Recruiter

Recruiter:         Debasis Banerjee

Email:               debasisb@askstaffing.com

Phone:              678-785-3670

Meet Your Recruiter

Debasis Banerjee
Team Lead - Recruitment & Delivery

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