Sr. Specialist, Quality Deviation Investigator
Bothell, Washington, US Bothell, WA 00000
Job Title: Sr. Specialist, Quality Deviation Investigator
Location: Bothell, Washington, US
Job Type: Contract
Duration: 0-6 Months
- 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
- 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
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Recruiter: Debasis Banerjee