APQR Program Lead: Quality Analytics & Compliance

Tris Pharma, Inc.; New Jersey; On-site; USD 100,000 - 145,000; Full time

Benefits offered by this job

Medical insurance

401K with match

Paid time off

Bonus eligible

Job summary

Tris Pharma, Inc. in Monmouth Junction, NJ, seeks an Annual Product Quality Review (APQR) Program Lead to support QA by merging product data evaluation with engineering controls ensuring safety, identity, strength, quality and purity.

You will lead statistical trending, data collection, and APQR/APR drafting to monitor product/process stability and drive data-driven continuous improvement in line with cGMPs.

Qualifications

• Bachelor’s degree in Chemical Engineering, Pharmaceutical Sciences, Chemistry, or related science and 5+ years in quality systems, process validation or product quality review in pharma/biotech.
• Fluency in English (verbal and written) and strong communication skills.
• Strong knowledge of FDA quality systems, cGMPs and APQR/APR processes.
• Experience applying statistical methods (control charts, regression, ANOVA) and data visualization.

Responsibilities

• Maintain QA documentation in line with SOPs and cGMPs.
• Lead evaluation of annual product quality data and identify risks for continuous improvement.
• Host APR risk assessment meetings and track actions.
• Perform advanced trend analysis on CQAs/CPPs and report trends.
• Coordinate cross-functional teams to address deviations, CAPAs, and changes.
• Support regulatory inspections as SME for APQRs and statistics.

Skills

Statistical analysis

Quality risk management

Data interpretation

Communication skills

English fluent

Independent worker

Attention to detail

Education

Bachelor’s degree in Chemical Engineering or related science

Tools

Minitab

JMP

SAS

Power BI

Job description

Tris Pharma, Inc. in Monmouth Junction, NJ, seeks an Annual Product Quality Review (APQR) Program Lead to support QA by merging product data evaluation with engineering controls ensuring safety, identity, strength, quality and purity.

You will lead statistical trending, data collection, and APQR/APR drafting to monitor product/process stability and drive data-driven continuous improvement in line with cGMPs.