Quality Assurance Specialist

Specialist I, QA QMS for Tris Pharma, Inc to work at our Monmouth Junction, NJ loc. Will support + assist QA function in ensuring manufacturing QC + procedures are followed in accordance w/ SOPs, current Good Manufacturing Practices (cGMP), FDA standards + batch record specifications. Support operational needs + activities to achieve qualify goals + metrics across multiple quality functions including: documentation, maintenance + tracking, compliance, + operations. May assist in maintenance + tracking of all Quality related documentation including: Investigations, CAPAs/CPIs, Planned Deviations, + Product Quality Complaints. Maintain all Quality related documentation, as assigned while ensuring adherence to, + compliance w/, established company quality policies, practices, SOPs + cGMPs. Work w/ 3rd party company, pharmacy, patients on conducting product quality compliant investigation + ensure proper escalation of issues. Report metrics pertaining to investigations of lab OOS/OOT/Lab Event, CAPAs/CPIs, planned deviations + product quality complaints to Quality Department Head or other appropriate company personnel. Assist w/ SOP revision + inspections. Assist w/ other areas of QA and cross train as needed. May undergo background checks including drug screening. Salary $81,037/yr plus comprehensive benefits (A complete list of benefits can be found at trispharm.com/connect/careers). Requirements Must have Bachelor’s in Mechanical Engineering or related science field and 2 years of relevant GMP experience in the pharmaceutical or biotechnology industry. 2 years of 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 determination and closure of investigations within defined timelines. Conducting investigations, root cause analysis, CAPA or CPI in accordance with Quality System. Tracking and trending quality metrics for open Investigations: lab OOS/OOT/Lab Event, CAPAs/CPIs, planned deviations, and product quality complaints. #J-18808-Ljbffr