Senior QA Specialist: CAPA, GMP & Compliance Leader

Veg Group; Barceloneta (PR); On-site; USD 70,000 - 90,000; Full time

Job summary

Validation & Engineering Group, Inc. in the United States (Puerto Rico) seeks a QA Specialist III to implement and maintain the Quality System and support manufacturing operations for events, investigations, and product disposition.

The role requires strong English/Spanish communication, GMP knowledge, and experience with CAPA, risk management, and SOP approvals, with potential for weekend hours and extended shifts as needed.

Qualifications

• Bachelor's degree in Biotechnology, Biology, Chemistry or Engineering.
• Experience in Quality preferably evaluating and conducting investigations.
• Teamwork and time management skills.
• Four (4) years of experience in Pharmaceutical/Biotechnology industry in a similar position.
• Knowledge of GMP, safety regulations.
• Excellent written and spoken communication skills in English and Spanish.
• Available to work extended hours, possibility of weekends and holidays.

Responsibilities

• Support routine operations to meet quality goals and comply with applicable regulations.
• Back up the QA Manager and assist quality initiatives.
• Lead investigations and risk-based evaluations for product disposition.
• Review SOPs, change management and calibration records.
• Ensure EHS compliance and cross-functional liaison with Manufacturing.

Skills

Quality management

Investigations

CAPA

Risk management

GMP knowledge

Education

Bachelor's degree in Biotechnology/ Biology/ Chemistry/ Engineering

Job description

Validation & Engineering Group, Inc. in the United States (Puerto Rico) seeks a QA Specialist III to implement and maintain the Quality System and support manufacturing operations for events, investigations, and product disposition.

The role requires strong English/Spanish communication, GMP knowledge, and experience with CAPA, risk management, and SOP approvals, with potential for weekend hours and extended shifts as needed.