Senior APQR Lead & Quality Systems Engineer

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

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401K with match

Paid Holidays

Job summary

Tris Pharma, Inc. in Monmouth Junction, NJ, seeks a Senior Quality Systems Engineer/APQR Lead to strengthen our QA function.

The role focuses on integrating product data evaluation under FDA 21 CFR 211.180(e) with engineering controls to keep products meeting safety, identity, strength, quality and purity standards. You will lead APQR/APR data collection, perform advanced trend analyses, drive Root Cause investigations, and coordinate with QA, Production and Validation to ensure compliance and

Qualifications

• Minimum 5 years in quality systems, process validation or QA in pharma/biotech.
• Deep understanding of FDA 21 CFR Part 210/211, ICH Q8/Q9/Q10.
• Proficiency with statistical tools (Minitab/JMP/SAS) for process trending and risk assessments.

Responsibilities

• Maintain QA documentation per SOPs and cGMPs.
• Lead evaluation of annual product quality data to identify risks and opportunities for improvement.
• Host APR risk assessment meetings and track team actions.
• Perform Advanced Trend Analysis on CQAs/CPPs and report trends.
• Drive root-cause investigations with QA, Production and Laboratories teams.
• Monitor process capability (Cp/Cpk) and CPV data across product lifecycles.

Skills

Statistical analysis

Quality systems

FDA compliance

Root cause analysis

Documentation management

Education

Bachelor's degree in Chemical Engineering, Pharmaceutical Sciences, Chemistry, or related discipline

Tools

Minitab

JMP

SAS

Power BI

Tableau

JMP Live

Spotfire

Job description

Tris Pharma, Inc. in Monmouth Junction, NJ, seeks a Senior Quality Systems Engineer/APQR Lead to strengthen our QA function.

The role focuses on integrating product data evaluation under FDA 21 CFR 211.180(e) with engineering controls to keep products meeting safety, identity, strength, quality and purity standards. You will lead APQR/APR data collection, perform advanced trend analyses, drive Root Cause investigations, and coordinate with QA, Production and Validation to ensure compliance and