Specialist I, QA Quality Management System

Description Specialist I, QA QMS for Tris Pharma, Inc to work at our Monmouth Junction, NJ location. Will support and assist the QA function in ensuring manufacturing QC and procedures are followed in accordance with SOPs, current Good Manufacturing Practices (cGMP), FDA standards and batch record specifications. Supports operational needs and activities to achieve quality goals and metrics across multiple quality functions including documentation, maintenance and tracking, compliance, and operations. May assist in maintenance and tracking of all quality related documentation including investigations, CAPAs/CPIs, planned deviations, and product quality complaints. Maintains all quality related documentation while ensuring adherence to company quality policies, practices, SOPs and cGMPs. Works with 3rd party companies, pharmacies, and patients on conducting product quality compliant investigations and ensures proper escalation of issues. Reports metrics pertaining to investigations of lab OOS/OOT/Lab events, CAPAs/CPIs, planned deviations, and product quality complaints to the Quality Department Head or other appropriate company personnel. Assists with SOP revision and inspections, other areas of QA, and cross trains as needed. May be subject to background checks including drug screening. Salary $81,037 per year plus comprehensive benefits. Requirements Must have a Bachelor's degree in Mechanical Engineering or a related science field and 2 years of relevant GMP experience in the pharmaceutical or biotechnology industry. Requires skills (minimum 2 years experience) in cGMPs in the pharmaceutical industry; issuing, tracking, and closing investigations, CAPAs, CPIs, planned deviations, and product quality complaint investigations; conducting investigations leading to root cause and closure within defined timelines; performing root cause analysis, CAPA or CPI in accordance with the Quality System; and tracking and trending quality metrics for open investigations: lab OOS/OOT/Lab events, CAPAs/CPIs, planned deviations, and product quality complaints. Apply at #J-18808-Ljbffr Tris Pharma