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.
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