QA Specialist II — Quality Systems & Compliance Lead

Pinnaql; Barceloneta (PR); On-site; USD 65,000 - 90,000; Full time

Job summary

Validation & Engineering Group Inc V&EG a Pinnaql company is seeking a dedicated QA Specialist II for a rotating 4-day, 10-hour shift to uphold the quality system and ensure regulatory compliance across pharmaceutical, biotechnology and related operations.

The role involves supporting manufacturing, leading investigations, CAPA and change management, and serving as a QA back-up to the QA Manager while maintaining rigorous documentation and EHS alignment.

Qualifications

• Bachelor's degree in Biotechnology, Biology, Chemistry or Engineering.
• Masters Degree preferred; four years of experience in Pharmaceutical/Biotechnology.
• Knowledge of GMP and safety regulations.
• Excellent written and spoken communication in English and Spanish.

Responsibilities

• Implement and maintain effectiveness of Quality System.
• Support manufacturing operations in events resolution and documentation discrepancies.
• Provide guidance for product/process impact analyses and investigations.
• Approve SOPs, change management and risk management documents.
• Ensure documents comply with global procedures and regulatory requirements.
• Support internal/external audits and new product introductions.

Education

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

Masters Degree preferred

Job description

Validation & Engineering Group Inc V&EG a Pinnaql company is seeking a dedicated QA Specialist II for a rotating 4-day, 10-hour shift to uphold the quality system and ensure regulatory compliance across pharmaceutical, biotechnology and related operations.

The role involves supporting manufacturing, leading investigations, CAPA and change management, and serving as a QA back-up to the QA Manager while maintaining rigorous documentation and EHS alignment.