Senior QA Specialist & Cross-Functional Quality Lead

Frey Consulting Group; Juncos (PR); On-site; USD 90,000 - 120,000; Full time

Job summary

Frey Consulting Group is seeking a Senior Specialist QA to support the site's Quality Assurance program. The role focuses on reviewing and approving manufacturing documentation, supporting QA and manufacturing teams, and leading investigations across validation, quality systems and processes.

The ideal candidate will have advanced education in a related field and substantial experience in CSV, GMP compliance, and cross-functional collaboration.

Qualifications

• Doctorate + 2 years of directly related experience
• Master's Degree + 4 years of directly related experience
• Bachelor's Degree + 6 years of directly related experience
• Associate Degree + 10 years of directly related experience
• High School Diploma/GED + 12 years of directly related experience

Responsibilities

• Review and approve Product Manufacturing documentation.
• Approve process validation protocols and reports for manufacturing processes.
• Lead and support quality investigations and cross-functional activities.
• Own and maintain site Quality program procedures.
• Serve as QA Manager's designee on CCRB and collaborate on regulatory matters.

Skills

Cross-functional teams

QA leadership

Documentation review

Regulatory compliance

Risk management

Data trending

Education

Doctorate

Master's Degree

Bachelor's Degree

Associate Degree

High School Diploma/GED

Tools

KNEAT

CDOCS

SCADA

TrackWise

Job description

Frey Consulting Group is seeking a Senior Specialist QA to support the site's Quality Assurance program. The role focuses on reviewing and approving manufacturing documentation, supporting QA and manufacturing teams, and leading investigations across validation, quality systems and processes.

The ideal candidate will have advanced education in a related field and substantial experience in CSV, GMP compliance, and cross-functional collaboration.