Specialist I, QA Quality Management System

Tris PharmaMonmouth Junction, NJ

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Overview

Schedule

Full-time

Education

Engineering (PE)

Career level

Senior-level

Remote

On-site

Benefits

Health Insurance

Job Description

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Description

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/.

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FAQs About Specialist I, QA Quality Management System Jobs at Tris Pharma

What is the work location for this position at Tris Pharma?

This job at Tris Pharma is located in Monmouth Junction, NJ, according to the details provided by the employer. Some roles may also include multiple work locations depending on the requirement.

What pay range can candidates expect for this role at Tris Pharma?

Employer has not shared pay details for this role.

What employment applies to this position at Tris Pharma?

Tris Pharma lists this role as a Full-time position.

What experience level is required for this role at Tris Pharma?

Tris Pharma is looking for a candidate with "Senior-level" experience level.

What education level is required for this job?

The education requirement for this position is Engineering (PE). Candidates with relevant qualifications or equivalent experience may also be considered.

What benefits are offered by Tris Pharma for this role?

Tris Pharma offers Health Insurance for this position. Actual benefits may vary depending on the employer's policies and employment terms.

What is the process to apply for this position at Tris Pharma?

You can apply for this role at Tris Pharma either through Sonara's automated application system, which helps you submit applications 10X faster with minimal effort, or by applying manually using the direct link on the job page.