The main point of contact with the quality control unit at each facility that manufactures Kao USA products to ensure finished goods meet Kao USA quality standards, and leader of process improvement processes.
This is a level two position; Quality Assurance Specialist II.
Leadership of one of the FDA regulated, drug product surveillance processes: QA Consumer Complaint Investigations, Corrective and Preventative Action program, Annual Drug Product Review process.
Audit potential and existing manufacturers with respect to cGMP compliance and Kao USA requirements, prepare reports, make recommendations and review with management.
Document and review situations of non-conformance of process, procedures, components or finished goods. Drive investigation as warranted, develop and implement corrective and preventative actions.
Statistically analyze production data and recommend revision of process or product specifications if warranted by the data to ensure process capability.
Provide Quality Assurance leadership and support to assigned Brands and associated manufacturing facilities to ensure successful and on-time new product launches. Audit to ensure on-going production meets Kao USA standards.
Review, evaluate and approve drug product master production instruction, validation protocols and summary reports. Evaluate and assess proposed changes to drug product processes. Gather, summarize and review pertinent information for Annual Drug Product Review.
Bachelor of Arts/ Science
American Society of Quality certification: Quality Auditor, Pharmaceutical current Good Manufacturing Practices (cGMP) Professional or equivalent
3-5 years experience in Quality Assurance (QA) with excellent demonstrated knowledge of cGMP
3-5 years experience of Statistical Process Control to evaluate process capability
Demonstrated ability to lead one of the Food & Drug Administration (FDA) regulated surveillance processes: QA Consumer
Complaint Investigations, Corrective and Preventative Action program, Annual Drug Product Review process
Ability to communicate and influence, without authority to effect change
Perseverance in investigations of non-conformances to ensure true root cause is derived and effective corrective actions are implemented
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