QA Specialist II - GMP, Validation & CAPA

Veg Group; Barceloneta (PR); On-site; USD 70,000 - 100,000; Full time

Benefits offered by this job

Equal opportunity employer

Job summary

Validation & Engineering Group, Inc. is seeking a QA Specialist II to support manufacturing operations and maintain the quality system in a fast-paced environment.

The role includes handling events, CAPA, risk-based evaluations, and product disposition with strong collaboration across QA and manufacturing teams. The candidate should have a Bachelor’s in biotechnology, biology, chemistry or engineering, plus 4 years in pharma/biotech, with English and Spanish proficiency and knowledge of GMP and

Qualifications

• Bachelor's degree in Biotechnology, Biology, Chemistry or Engineering required.
• Four (4) years of experience in Pharmaceutical/Biotechnology industry in a similar position.
• Knowledge of GMP, quality/compliance, investigations and risk management.
• Excellent written and spoken communication in English and Spanish.

Responsibilities

• Implement and maintain the quality system and ensure regulatory compliance.
• Lead investigations, risk assessments, and CAPA activities for plant events.
• Review and approve investigations, change controls, and SOPs; support audits.
• Provide guidance for product disposition and material control until regulatory approval.
• Collaborate with QA Manager and manufacturing to meet quality goals.

Skills

Quality management

Investigation & CAPA

Regulatory compliance

Bilingual English/Spanish

Education

Bachelor's degree in Biotechnology, Biology, Chemistry or Engineering

Masters Degree in Science preferred

Job description

Validation & Engineering Group, Inc. is seeking a QA Specialist II to support manufacturing operations and maintain the quality system in a fast-paced environment.

The role includes handling events, CAPA, risk-based evaluations, and product disposition with strong collaboration across QA and manufacturing teams. The candidate should have a Bachelor’s in biotechnology, biology, chemistry or engineering, plus 4 years in pharma/biotech, with English and Spanish proficiency and knowledge of GMP and