Senior QA Specialist – CAPA, Validation & Compliance

Validation & Engineering Group, Inc.; Barceloneta (PR); On-site; USD 70,000 - 110,000; Full time

Job summary

Validation & Engineering Group, Inc. is seeking a QA Specialist III to implement and maintain the Quality System and support manufacturing operations. You will review investigations, assess product/process impact, and guide risk evaluations to ensure compliant disposition of products.

The role requires coordinating with multiple teams and ensuring CAPA and regulatory requirements are met. Strong knowledge of GMP and EHS practices is essential for success in this fast-paced environment.

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.
• Quality/compliance management skills.
• Available to work extended hours, possibility of weekends and holidays.

Responsibilities

• Support routine operations to ensure quality goals are met and procedures comply with policies and regulations.
• Serve as backup for the QA Manager leading the team and supporting quality initiatives.
• Ensure investigations of plant events are evaluated in a timely and thorough manner.
• Perform product impact analyses and place products on QA hold when appropriate.
• Participate on the Validation Review Board as the Manufacturing QA function.
• Approve SOPs, change management and risk management documents, ensuring regulatory compliance.

Skills

Quality assurance

Investigations

Teamwork

Time management

English and Spanish communication

Education

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

Job description

Validation & Engineering Group, Inc. is seeking a QA Specialist III to implement and maintain the Quality System and support manufacturing operations. You will review investigations, assess product/process impact, and guide risk evaluations to ensure compliant disposition of products.

The role requires coordinating with multiple teams and ensuring CAPA and regulatory requirements are met. Strong knowledge of GMP and EHS practices is essential for success in this fast-paced environment.