Specialist I, QA Quality Management System

Tris Pharma Inc•South Brunswick, NJ

5d•$81,037•Onsite

About The Position

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.

Requirements

Bachelor’s in Mech Engineering or related science field
2 years related GMP experience in the pharmaceutical or biotechnology industry
2 years experience in cGMPs in the pharmaceutical industry
2 years experience in Issuing, tracking and closing Investigations, CAPAs, CPIs, Planned Deviations and Product Quality Complaint Investigations
2 years experience in conducting investigations leading to root cause and closure of investigations within defined timelines
2 years experience in conducting investigations, root cause analysis, CAPA or CPI in accordance with Quality System
2 years experience in tracking and trending quality metrics for open Investigations: lab OOS/OOT/Lab Event, CAPAs/CPIs, planned deviations, and product quality complaints

Responsibilities

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.
Support operational needs and activities to achieve quality goals and metrics across multiple quality functions including: documentation, maintenance and tracking, compliance, and operations.
Assist in the maintenance and tracking of all Quality related documentation including: Investigations, CAPAs/CPIs, Planned Deviations, and Product Quality Complaints.
Maintain all Quality related documentation, as assigned while ensuring adherence to, and compliance with, established company quality policies, practices, SOPs and cGMPs.
Work with 3rd party company, pharmacy, patients on conducting product quality compliant investigation and ensure proper escalation of issues.
Report metrics pertaining to investigations of lab OOS/OOT/Lab Event, CAPAs/CPIs, planned deviations and product quality complaints to Quality Department Head or other appropriate company personnel.
Assist with SOP revision and inspections.
Assist with other areas of QA and cross train as needed.