Specialist I, QA Quality Management System

Tris Pharma•Monmouth Junction, NJ

5d•$81,037•Onsite

About The Position

Tris Pharma, Inc. is seeking a Specialist I, QA QMS at our Monmouth Junction, NJ location. This role 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. The position supports operational needs and activities to achieve quality goals and metrics across multiple quality functions, including documentation, maintenance and tracking, compliance, and operations. The role may involve assisting in the maintenance and tracking of all Quality related documentation, such as Investigations, CAPAs/CPIs, Planned Deviations, and Product Quality Complaints. The Specialist will maintain all assigned Quality related documentation, ensuring adherence to and compliance with established company quality policies, practices, SOPs, and cGMPs. This role will also work with third-party companies, pharmacies, and patients on conducting product quality complaint investigations and ensuring proper escalation of issues. The Specialist will 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 company personnel. Responsibilities include assisting with SOP revision and inspections, and assisting with other areas of QA and cross-training as needed. Background checks, including drug screening, may be required.

Requirements

Bachelor’s in Mechanical Engineering or related science field.
2 years of related GMP experience in the pharmaceutical or biotechnology industry.
2 years of experience in cGMPs in the pharmaceutical industry.
2 years of experience in issuing, tracking and closing Investigations, CAPAs, CPIs, Planned Deviations and Product Quality Complaint Investigations.
2 years of experience in conducting investigations leading to root cause and closure of investigations within defined timelines.
2 years of experience in conducting investigations, root cause analysis, CAPA or CPI in accordance with Quality System.
2 years of 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, 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 complaint 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.