Sr QA Specialist

Sr QA Specialist
  • $50 - $78 per Hour
  • Temporary
  • Santa Monica CA, US Santa Monica LOS ANGELES US 90404
Job Ref: JO000119143
Sector: Clinical
Sub-sector: Quality
Date Added: 17 June 2021

SR QA Specialist


  • -Disposition raw materials globally for Kite manufacturing network
    -Review material related documentation and ensure resolution of issues to release material
    -Ensures alignment of the disposition process with other quality systems (Deviation, CAPA, validation, jurisdictional control etc.)
    -Owner of disposition training curriculum; Provide training to new sites
    -QA approver for LIR, deviation, CAPA and change control records owned by raw material QC group
    -Ensure all material-related Deviations and CAPAs are initiated, investigated and resolved per establish procedures
    -QA approver on QC labs and CTL OOS investigations including analytical and microbiology testing
    -Approver of analytical methods validation and qualification protocols, data and reports
    -Ensure timely closure and effectiveness of investigations and corrective and preventive actions.
    -Ensure effective root cause analysis and implement corrective action and preventative action.
    -Execute Quality walk through for QC Lab for raw material testing
    -Oversee material qualification process, approve material qualification protocols, reports
    -Oversee material specification lifecycle process, approve specification initiation, changes and obsolescence.
    -Support regulatory inspections, internal audits, and external audits from partners.
    -Review technical/ investigation reports as appropriate.
    -Review and approve proposed changes to procedures.
    -Provide QA guidance to material development projects and technical transfer activities.
    -Provide data for Quality related metrics
    -Participate in Material Review Board meetings to ensure non-conforming material is appropriately dispositioned.
    -Up to 10% domestic travel
    -Perform duties as needed

SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.

13/01/2022 12:00:00
USD 50.00 78.00 Hour
Contact Consultant:
Hilary Purtz

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