QA Specialist: Compliance, CAPA & Audit Lead

BioPharma Consulting JAD Group; Juncos (PR); Hybrid; USD 89,000 - 134,000; Full time

Job summary

BioPharma Consulting JAD Group seeks a QA professional to perform a broad range of quality assurance activities across GMP documentation, investigations, and environmental programs. You will lead root-cause investigations, support audits, and provide lot disposition for product release.

The role requires leading cross-functional QA tasks, maintaining site quality procedures, and collaborating with regulatory bodies to ensure compliant operations.

Qualifications

• Advanced degree with related QA/GxP experience.
• On-the-floor QA exposure with cGMP processes.
• Experience supporting audits and inspections.
• Strong data analysis and trend evaluation.

Responsibilities

• Review and approve GMP documentation and change controls.
• Lead investigations and ensure timely closure.
• Support audits and inspections as part of the team.
• Provide lot disposition for product release.
• Maintain site quality program procedures.
• Interact with regulatory agencies as needed.

Skills

Quality Assurance

Investigations

Data trending

Regulatory interaction

Project management

On-the-floor QA

Education

Doctorate

Master’s degree + 2 years

Bachelor’s degree + 4 years

Associate’s degree + 8 years

High School/GED + 10 years

Tools

TrackWise

SAP

Job description

BioPharma Consulting JAD Group seeks a QA professional to perform a broad range of quality assurance activities across GMP documentation, investigations, and environmental programs. You will lead root-cause investigations, support audits, and provide lot disposition for product release.

The role requires leading cross-functional QA tasks, maintaining site quality procedures, and collaborating with regulatory bodies to ensure compliant operations.