Specialist I, QA Quality Management System

Overview Specialist I, QA QMS for Tris Pharma, Inc. Responsibilities based in Monmouth Junction, NJ. The role supports and assists the QA function to ensure manufacturing QC procedures are followed in accordance with SOPs, current Good Manufacturing Practices (cGMP), FDA standards, and batch record specifications. Responsibilities Support operational needs and achieve quality goals and metrics across multiple quality functions including documentation, maintenance, compliance, and operations. Assist in maintenance and tracking of all quality‑related documentation such as investigations, CAPAs/CPIs, planned deviations, and product quality complaints. Maintain all quality‑related documentation while ensuring adherence to established company quality policies, practices, SOPs, and cGMPs. Work with third‑party companies, pharmacies, and patients on conducting product‑quality compliant investigations and properly escalating issues. Report metrics pertaining to investigations of lab OOS/OOT/Lab Event, CAPAs/CPIs, planned deviations, and product quality complaints to the Quality Department Head or other appropriate personnel. Assist with SOP revision and inspections. Assist with other areas of QA and cross‑train as needed. Undergo background checks, including drug screening. Qualifications Bachelor’s degree in Mechanical Engineering or related science field. Minimum two years related GMP experience in the pharmaceutical or biotechnology industry. Experience in cGMPs within the pharmaceutical industry. Skill in issuing, tracking, and closing investigations, CAPAs, CPIs, planned deviations, and product quality complaint investigations. Ability to conduct investigations, root‑cause analysis, and close investigations within defined timelines. Proficiency in root‑cause analysis, CAPA or CPI in accordance with the quality system. Experience tracking and trending quality metrics for open investigations: lab OOS/OOT/Lab Event, CAPAs/CPIs, planned deviations, and product quality complaints. Salary and Benefits Salary: $81,037 per year plus comprehensive benefits. #J-18808-Ljbffr Tris Pharma, Inc