One of our large pharmaceutical clients is looking to hrie a QC Investigator to join the QC team in Malvern PA. This individual is responsible for authoring nonconformance investigations and corrective and preventative action records, document management, investigation and assay trending, root cause problem solving, and human performance factors analysis. This position requires analytical thinking, organizational leadership, and technical writing skills. This position will drive improvements within a global organizational framework.
Responsibilities:
-Performs and documents all QC investigations (non-conformance, deviations, invalid assays)
-Authors and executes corrective and preventative action record
-Tracks deviations and events and provides reports to management on trending, and status as requested. Recommends corrective actions for any trends identified
-Manages change through chance control process
-May performs Gap Assessments for local QC documents against new standards and other quality documents
-Executes CAPAs when required for the Quality Control organization
-Works with compliance to provide QC input for the APR
-Reports data from QC as required for the site management review
-Maintains individual training completion in a compliant state
-May be asked to participate in audits
-Support Health Authority inspections
-Provide input to functional laboratory meetings
-Make decisions as a QC representative at cross-functional meetings
-Provide leadership and insight as a member of global project teams
-Provide QC input as a member of Quality focused projects

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