Kao USA is looking to ensure finished goods meet their quality standards by having a main point of contact with the quality control unit at each facility that manufactures their products.
Requirements
- Understanding of current Good Manufacturing Practices (cGMP)
- Some experience using Statistical Process Control
- Need to pass the American Society of Quality (ASQ) Lead Auditor Certification or equivalent
Responsibilities
- 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 at manufacturing sites. 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 ongoing 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.
Other
- Bachelor's degree in Arts/ Science
- 1+ years of experience in a Quality Unity role
- 36 total days off (vacation + holidays + sick)
- Reasonable salary range and benefits package
