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 trispharm.com/connect/careers).
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 https://www.trispharma.com/connect/careers/
Tris Pharma, Inc. is a leading privately-owned biopharmaceutical company in the U.S. Our focus is on the development and commercialization of innovative medicines that address unmet patient needs and we have more than 150 U.S. and International patents including applications. We market several branded and generic products in the U.S; license our products in the U.S. and international markets and we have a robust pipeline of innovative products, that employ our proprietary science and technology, to meet patients’ needs in neuroscience and other therapeutic categories.
Our science and technology make us unique, but it is our team members that set us apart; they are the engine that fuels Tris’ passion and innovation. The Tris team comprises of approximately 500 diverse individuals; one third of whom operate in the field throughout the U.S. while the other two-thirds work from Tris’ NJ operations.
Tris colleagues understand the criticality of operating a successful business and take pride in the company’s success. But of equal importance to each member of the team is how we interact with one another on a daily basis. We believe in each other and we believe in respectful, open and honest communications to help support individual and team success.
At Tris, we strive to ensure our field and home office teams are connected and engaged. We listen to our teams in numerous ways, including through our Diversity & Inclusion Committee and our Women’s Business Council, to help ensure every employee’s voice is heard. After all, it is our daily interactions with one another that build and sustain our culture, which fuels our growth.
