More jobs:
Specialist , QA Quality Management System
Job in
Monmouth Junction, Middlesex County, New Jersey, 08852, USA
Listed on 2026-06-27
Listing for:
Tris Pharma
Full Time
position Listed on 2026-06-27
Job specializations:
-
Quality Assurance - QA/QC
Data Analyst -
Healthcare
Job Description & How to Apply Below
Location: Monmouth Junction
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Description
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 ).
Requirements
Must have Bachelor's in Mech Engineering or rel science field and 2 yrs rel GMP exp in the pharmaceutical or biotechnology industry. Also requires skills (2 yrs exp) 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 of investigations within defined timelines; conducting investigations, root cause analysis, CAPA or CPI in accordance with Quality System; and tracking and trending quality metrics for open Investigations: lab OOS/OOT/Lab Event, CAPAs/CPIs, planned deviations, and product quality complaints. Apply at
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