Senior QA Specialist - Compliance & Validation

Pinnaql, Inc.; Barceloneta (PR); On-site; USD 75,000 - 105,000; Full time

Job summary

Validation & Engineering Group, Inc. (VEG), a Pinnaql company, is seeking a QA Specialist III to implement and maintain the Quality System and support manufacturing operations in investigation and risk-based evaluation activities.

You will review investigations, lead CAPA-related tasks, and ensure procedures comply with GMP and regulatory requirements. The role requires a Bachelor’s degree in biotechnology/biology/chemistry or engineering, 4 years in pharma/biotech, and excellent

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.
• Excellent written and spoken communication skills in English and Spanish.
• Available to work extended hours, possibility of weekends and holidays.

Responsibilities

• Support routine operations to ensure that quality goals are met and all practices and procedures comply with policies and applicable regulations for the Quality areas under responsibility.
• Serve as backup for the QA Manager leading the team and providing support to quality initiatives.
• Ensure investigations of plant events are evaluated in a timely manner and documented in the plant CAPA system.
• Perform product impact analyses for plant events and place product on QA hold where appropriate.
• Participate on the Validation Review Board as the Manufacturing Quality Assurance function.
• Approve SOPs; change management and risk management documents in compliance with global procedures and regulatory requirements.
• Approve calibration requests and preventive maintenance records with proper justifications.
• Demonstrate accountability for EHS performance and compliance.
• Maintain liaison with other Quality areas and Plant departments to ensure alignment with procedures.
• Provide support to the Compliance team during audits and assist with new product introduction risk assessments.

Skills

Bilingual English/Spanish

Teamwork

Education

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

Job description

Validation & Engineering Group, Inc. (VEG), a Pinnaql company, is seeking a QA Specialist III to implement and maintain the Quality System and support manufacturing operations in investigation and risk-based evaluation activities.

You will review investigations, lead CAPA-related tasks, and ensure procedures comply with GMP and regulatory requirements. The role requires a Bachelor’s degree in biotechnology/biology/chemistry or engineering, 4 years in pharma/biotech, and excellent