Quality Engineer: APQR & Data-Driven QA Leader

Tris Pharma, Inc.; South Brunswick (NJ); On-site; USD 100,000 - 145,000; Full time

Benefits offered by this job

Bonus eligible

Medical, dental, vision

401K with match

Paid PTO

Job summary

Tris Pharma, Inc. located in Monmouth Junction, New Jersey, seeks a Quality Engineer to support QA by merging product data evaluation with engineering controls under FDA standards.

You will lead statistical trending, APQR/APR oversight, and continuous improvement across manufacturing processes. The role requires a Bachelor’s in a scientific field and 5+ years in pharma quality systems, with expertise in FDA regulations, CPV data, and statistical tools.

Qualifications

• Bachelor's degree and 5+ years in quality systems, process validation or quality engineering in pharma/biotech.
• Knowledge of FDA 21 CFR Part 210/211, ICH Q8/Q9/Q10.
• Ability to translate statistics into risk assessments and business recommendations.
• Experience with CPV data, APQR/APR processes and regulatory timelines.

Responsibilities

• Maintains all quality documentation in line with SOPs and cGMPs.
• Leads evaluation of annual product quality data and identifies risks and improvement opportunities.
• Hosts APR risk assessment meetings and documents actions.
• Performs advanced trend analysis on CQAs/CPPs and validates process consistency.
• Evaluates deviations, CAPAs, change controls and stability data for quality decisions.
• Supports regulatory audits as SME for APQRs and data trends.

Skills

Fluent English

Statistical analysis

Quality Assurance

Documentation

Problem solving

Education

Bachelor's degree in Chemical Engineering, Pharmaceutical Sciences, Chemistry

Tools

Minitab

JMP

SAS

HPLC

Job description

Tris Pharma, Inc. located in Monmouth Junction, New Jersey, seeks a Quality Engineer to support QA by merging product data evaluation with engineering controls under FDA standards.

You will lead statistical trending, APQR/APR oversight, and continuous improvement across manufacturing processes. The role requires a Bachelor’s in a scientific field and 5+ years in pharma quality systems, with expertise in FDA regulations, CPV data, and statistical tools.