QA Specialist II: Drive Quality & Compliance in Pharma Ops

Validation & Engineering Group, Inc.; Barceloneta (PR); On-site; USD 65,000 - 90,000; Full time

Job summary

Validation & Engineering Group, Inc. is seeking a QA Specialist II to support manufacturing operations, investigate events, and ensure compliance with GMP and EHS standards.

The role includes leading investigations, risk assessments, CAPA documentation, and coordination with QA and plant teams. The position requires a Bachelor's (or higher) in a scientific or engineering field, with 4 years of pharmaceutical/biotech experience, and fluency in English and Spanish.

Qualifications

• Bachelor’s degree in Biotechnology, Biology, Chemistry or Engineering; Master’s preferred.
• Four years of experience in Pharmaceutical/Biotechnology industry in a similar position.
• Knowledge of GMP and safety regulations.
• Excellent written and spoken English and Spanish.
• Subject to work with multiple priorities and interruptions under pressure.

Responsibilities

• Support routine operations to ensure quality goals and compliance.
• Lead investigations and CAPA documentation in the plant.
• Perform product impact analyses and QA holds when needed.
• Participate on the Validation Review Board and approve SOPs and change management docs.
• Approve calibration requests and maintain records with proper justifications.
• Demonstrate EHS accountability and liaise with QA and Plant departments.
• Oversee manufacturing operations for alignment with procedures.
• Support internal and external audits.
• Provide guidance for new product introductions and risk assessments.

Skills

Quality systems

Investigations

Risk management

Bilingual EN/ES

GMP knowledge

Education

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

Master’s degree in Science preferred

Job description

Validation & Engineering Group, Inc. is seeking a QA Specialist II to support manufacturing operations, investigate events, and ensure compliance with GMP and EHS standards.

The role includes leading investigations, risk assessments, CAPA documentation, and coordination with QA and plant teams. The position requires a Bachelor's (or higher) in a scientific or engineering field, with 4 years of pharmaceutical/biotech experience, and fluency in English and Spanish.