■Position Summary & Job Description
Support the QC Lab Lead for a particular shift and/or lab function in planning, organizing, implementing and controlling the daily activities of the QC laboratory to ascertain that raw materials, mass and finished goods meet internal and external specifications. Responsible for overseeing lab testing processes with ability to troubleshoot instruments and issues. Conduct and supervise all OOS investigations and reject investigations. Manage QC lab equipment, qualification protocols and reports, and administration. Participate in continuous improvement projects regionally to drive efficiencies in the lab. Flexible to support off-shift work when needed.
・Management of QC Lab Testing for a shift or lab function (50%)
- Support the QC Lab Lead for a particular shift and/or lab function in planning, organizing, implementing and controlling the daily activities of the QC laboratory to ascertain that both raw materials and assay of finished goods/mass meet internal and external specification. This includes management for lab workflow, sample analysis, sample retention, standards management, raw material qualification, TPM testing, outsourced testing, inventory management and document management
- Ensure execution of data integrity checks / verifications per procedures
- Provide QC expertise to plant hygiene program and lead corrective action based on findings
- Ensure there is testing support in relation to the environmental monitoring program and any associated risk assessments
- Identify SOPs and support QC Lab Lead in work instruction updates or creating new based on lab trends and CAPAs.
- Review SOPs and work instructions and provide to QC Lab Lead for approval.
- Review and trending of OOS, CAPAs and deviations related to their QC lab function
・Testing Data Review and Release - Data Reviewer role responsibilities (10%)
- Review of routine supporting test data and results, including sample preparation records, chromatograms / graphs, logbooks, calculations, and data sheets. Enter results in SAP/LIMS.
- Release of raw materials, non-OTC mass, and Cosmetic FGs in SAP
- Review of non-routine supporting test data and results (i.e. micro testing for water systems, validation testing)
・Equipment Program (10%)
- Manage QC lab equipment budget, equipment purchases, installation and initiate change control as needed
- Development of lab equipment qualification (IQ/OQ/PQ) protocols and reports
- Manage specific area’s equipment administration, including calibration, preventive maintenance, and troubleshooting as needed
・Compliance / Continuous Improvement within Lab Function Area (10%)
- Ensure all lab processes are adhering to relevant regulatory GMPs and global company policies & procedures
- Participate in internal audits to ensure regulatory readiness
- Work collaboratively with Planning, GBSC, QA Labs, Manufacturing, Validation, and Operations to drive continuous improvement.
- Monitor lab KPIs and drive improvements
- Ensure all customer complaints are investigated, improvements implemented and response made in a timely manner
・Personnel Management & Training (20%)
- Apply QC Lab objectives to their lab function area and conduct performance reviews against those objectives.
- Provide the coaching, mentorship and training necessary to support ongoing personal and professional development of QC lab staff (GMP and refresher training)
- Assist in the development and execution of quality training curriculum for the laboratory
■休日：完全週休二日制, GW, 祝日, 年末年始, 土, 夏季休暇, 日