Senior QA Specialist: GMP & Compliance

Veg Group; Barceloneta (PR); On-site; USD 90,000 - 130,000; Full time

Job summary

Validation & Engineering Group, Inc. in the Puerto Rico region seeks a QA Specialist III to uphold the Quality System and support manufacturing operations. You will evaluate events, conduct impact analyses, review investigations, and contribute to product disposition in a regulated environment.

Responsibilities include leading investigations, approving SOPs and change controls, supporting CAPA workflows, and assisting with audits. Fluency in English and Spanish and GMP knowledge are essential.

Qualifications

• Bachelor’s degree in Biotechnology, Biology, Chemistry or Engineering.
• Four+ years of Pharmaceutical/Biotechnology experience in a similar role.
• English and Spanish language proficiency in communication.
• Knowledge of GMP and safety regulations.

Responsibilities

• Support manufacturing operations resolving events, impact assessment and discrepancies.
• Lead investigations and risk-based evaluations; approve CAPA and changes.
• Provide QA guidance for new product introductions and product disposition.
• Back up QA Manager and ensure compliance with global procedures.

Skills

English/Spanish communication

GMP knowledge

Quality/compliance management

Education

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

Masters degree in Science (preferred)

Job description

Validation & Engineering Group, Inc. in the Puerto Rico region seeks a QA Specialist III to uphold the Quality System and support manufacturing operations. You will evaluate events, conduct impact analyses, review investigations, and contribute to product disposition in a regulated environment.

Responsibilities include leading investigations, approving SOPs and change controls, supporting CAPA workflows, and assisting with audits. Fluency in English and Spanish and GMP knowledge are essential.