Position Summary & Job Description
Quality Operations Specialist is responsible for quality assurance activities related, but not limited to, incoming raw materials & components, manufacturing floor operations (compounding, filling, utilities and warehouse), and suppliers. Quality assurance activities include leading deviation handling, root cause analysis and CAPA development, material management (Packaging components), managing components inspection, conducting document reviews to verify effectiveness of procedures and instructions, and providing training and coaching to Quality and Operations on SOP, GMP and root cause analysis.

Issues Resolution/Continuous Improvement (60%)
⚫Identify and review deviations, determine root cause, and develop CAPAs in collaboration with Quality, Operations and suppliers to address product quality issues and GMP related activities
⚫Certify CAPA completion and effectiveness
⚫Escalate critical issues to Quality/Operations leadership as required
⚫Investigate critical customer and consumer complaints
⚫Disposition out-of-spec materials, as directed
⚫Monitor progress against improvement initiatives identified by Quality Engineers, CI and ME

Document Review & Auditing (30%)
⚫Conduct documentation reviews in the plant (production, importation and compounding as applicable) for compliance with existing procedures and instructions, and verify the effectiveness of procedures and instructions versus EL requirements and needs
⚫Perform final review of executed batch, filling records, Incoming inspection of components and disposition products/materials
⚫Initiate, revise and review controlled documentation including procedures, investigations, deviations, and reports.
⚫Participate in routine GMP audits in the plant
Training/Coaching (10%)
⚫Provide training and coaching to Quality and Operations, on topics such as SOP, GMP and root cause analysis
⚫Perform other responsibilities, as assigned