Specialist , QA QMS

Specialist I, QA QMS for Tris Pharma, Inc. Position located in Monmouth Junction, NJ.

The role supports the QA function to ensure manufacturing QC and procedures are followed in accordance with SOPs, cGMP, FDA standards, and batch record specifications. The specialist will support operational needs and activities to achieve quality goals and metrics across multiple quality functions, including documentation, maintenance and tracking, compliance, and operations.

Responsibilities:

• Assist in maintenance and tracking of all quality related documentation, including investigations, CAPAs/CPIs, planned deviations, and product quality complaints.
• Conduct investigations leading to root‑cause analysis and closure of investigations within defined timelines.
• Perform root‑cause analysis, CAPA or CPI in accordance with the Quality System.
• Track and trend quality metrics for open investigations, including lab OOS/OOT/Lab events, CAPAs/CPIs, planned deviations, and product quality complaints.

Qualifications:

• Bachelor’s degree in mechanical engineering or a related science field.
• Two years of experience in GMP within the pharmaceutical or biotechnology industry.
• Two years of experience with cGMP, issuing, tracking, and closing investigations, CAPAs, CPIs, planned deviations, and product quality complaint investigations.
• Experience conducting investigations, root‑cause analysis, CAPA or CPI in accordance with a Quality System.
• Experience tracking and trending quality metrics for investigations.

Salary: $81,037 per year plus comprehensive benefits.