overview
- Orchestrate quality improvement initiatives by interfacing closely with multidisciplinary teams, such as Manufacturing, Engineering
- R&D, Procurement, and Quality (over 200+ employees), to make recommendations on optimizing the production and quality processes by
- Champion the CAPA/NCR/CCR systems, while implementing robust process controls and driving impactful changes to enhance the quality and consistency of raw materials, components, finished goods, and equipment, by trending and monitoring SPC data, resulting in consistent product quality that meets customer specification requirements, and reducing open CAPAs, NCRs, and CCRs by 60
- Demonstrate expertise as a site SAP SME/Super User, by collaborating with multidisciplinary teams to migrate inventory operations from AS400 to SAP, developing and implementing comprehensive training programs, including hands-on workshops and user manuals for over
- 100+ employees in the QA & QC departments
- Author and regulate equipment, cleaning, and process verification/validation protocols (i.e., Validation Plans, IQ/OQ/PQ protocols, validation summary reports), by collecting and analyzing data, and ensuring the statistical significance and effectiveness of each plan
- Revise and amend SOPs to ensure continuous improvement, monitor that all specifications are met for any given product or procedure, and suggest methods to bring equipment and practices into compliance with quality assurance standards
- Initiate internal audits to ensure compliance of GMP, GDP, HACCP, etc. with internal and external regulatory standards, and present audit
- Direct ad-hoc risk assessments for non-conforming material by collaborating with Manufacturing, R&D, and Quality teams to make