Specialist I, QA QMS

Specialist I, QA QM Sfor 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. (A complete list of duties and benefits can be found at trispharma.com/connect/careers). May undergo background checks including drug screening. Salary $81,037/yr plus comprehensive benefits.Must have Bachelors 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 https://www.trispharma.com/connect/careers/.

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