Quality Engineer: Data-Driven GMP & APQR Expert

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

Benefits offered by this job

Bonus eligible

Medical insurance

Dental insurance

401K with match

Paid holidays

PTO

Job summary

Tris Pharma, Inc. in Monmouth Junction, New Jersey, is seeking a Quality Engineer to support QA by merging data evaluation with engineering controls to ensure product quality and compliance.

The role leads statistical trending, APQR/APR drafting, and data-driven continuous improvement across manufacturing processes in line with cGMPs and FDA standards. The incumbent will maintain quality documentation, evaluate quality data for risks, conduct advanced trend analysis, support regulatory

Qualifications

• Bachelor-level degree in a chemical/Pharma field with 5+ years of quality engineering experience.
• Strong knowledge of FDA 21 CFR Part 210/211 and ICH Q8/9/10.
• Proficiency in statistical analysis and quality risk management.

Responsibilities

• Maintain quality documentation and ensure SOP/cGMP compliance.
• Lead evaluation of annual product quality data and identify risks.
• Perform advanced trend analysis and evaluate CQAs/CPPs.
• Drive root cause investigations and support inspections.
• Collaborate across departments to prepare APQRs/APRs.

Skills

Quality Systems

Process Validation

Regulatory Audits

Risk Management

Education

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

Tools

Minitab

JMP

SAS

Job description

Tris Pharma, Inc. in Monmouth Junction, New Jersey, is seeking a Quality Engineer to support QA by merging data evaluation with engineering controls to ensure product quality and compliance.

The role leads statistical trending, APQR/APR drafting, and data-driven continuous improvement across manufacturing processes in line with cGMPs and FDA standards. The incumbent will maintain quality documentation, evaluate quality data for risks, conduct advanced trend analysis, support regulatory