Senior QA Specialist: Lead Quality & Compliance (Contract)

Biopharma-Consulting-Jad-Group; Juncos (PR); On-site; USD 90,000 - 130,000; Full time

Job summary

Biopharma-Consulting-Jad-Group seeks a Sr Specialist, Quality Assurance to provide technical QA leadership in a regulated manufacturing environment. You will review product documentation, validation protocols, environmental reports, and quality records while supporting cross‑functional teams and site quality programs.

The role requires advanced data trending, investigative skills, and strong regulatory understanding to ensure compliance with internal standards and regulatory expectations.

Qualifications

• Experience in regulated manufacturing and QA systems.
• Ability to review and approve MPs, validation protocols, and QA records.
• Strong data trending, investigations, and quality event closure.
• Effective written and verbal communication for cross‑functional teams.

Responsibilities

• Review and approve MPs and manufacturing procedures.
• Approve validation protocols and environmental reports.
• Lead investigations and ensure timely closure.
• Own site quality program procedures and change controls.
• Support audit readiness and regulatory interactions.

Skills

QA compliance

Validation

Documentation

Data trending

Cross-functional collaboration

Regulatory awareness

Problem solving

Communication

Education

Doctorate + 2 years of experience

Master’s + 4 years of experience

Bachelor’s + 6 years of experience

Associate’s + 10 years of experience

High School/GED + 12 years of experience

Tools

KNEAT

CDOCS

SCADA

TrackWise

Maximo

Job description

Biopharma-Consulting-Jad-Group seeks a Sr Specialist, Quality Assurance to provide technical QA leadership in a regulated manufacturing environment. You will review product documentation, validation protocols, environmental reports, and quality records while supporting cross‑functional teams and site quality programs.

The role requires advanced data trending, investigative skills, and strong regulatory understanding to ensure compliance with internal standards and regulatory expectations.