Quality Engineer - Data-Driven GMP Analytics

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 insurance

Job summary

Tris Pharma, Inc. in Monmouth Junction, NJ is seeking a Quality Engineer to support QA data evaluation and regulatory compliance. You will lead data trending, APQRs/APRs, and continuous improvement initiatives across manufacturing and quality systems.

The role requires strong statistics knowledge, proficiency with software tools (Minitab/JMP/SAS), and collaboration with cross-functional teams to ensure product safety and quality.

Qualifications

• Bachelor-level degree in a chemical/pharmaceutical science or related field with 5+ years in quality systems, process validation or QA in pharma/biotech.
• Deep understanding of FDA 21 CFR Part 210/211 and ICH guidelines.
• Proficiency with statistical tools and data trending for APQR/APR.
• Fluent in English with strong communication and teamwork.
• Ability to work independently in a fast-paced environment.

Responsibilities

• Maintain quality documentation in accordance with SOPs and cGMPs.
• Lead evaluation of annual product quality data to identify risks and opportunities for improvement.
• Host APR risk assessment meetings and track actions.
• Perform advanced trend analysis across multiple product data streams.
• Conduct root cause investigations using structured problem-solving tools.
• Monitor process capability and report on Cpk/Ppk and stability trends.
• Support regulatory audits as SME for APQRs and statistics.

Skills

Statistical analysis

Quality engineering

FDA compliance

Excellent communication

Problem solving

Education

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

Tools

Minitab

JMP

SAS

Power BI

Job description

Tris Pharma, Inc. in Monmouth Junction, NJ is seeking a Quality Engineer to support QA data evaluation and regulatory compliance. You will lead data trending, APQRs/APRs, and continuous improvement initiatives across manufacturing and quality systems.

The role requires strong statistics knowledge, proficiency with software tools (Minitab/JMP/SAS), and collaboration with cross-functional teams to ensure product safety and quality.