Senior QA Specialist: CAPA, Validation & Compliance

Veg Group; Northern (KY); Hybrid; USD 85,000 - 115,000; Full time

Job summary

Validation & Engineering Group, Inc. (V&E G) seeks a QA Specialist III to implement and maintain the Quality System and support manufacturing operations. The role involves impact assessments, investigations, CAPA, and ensuring product disposition in a regulated environment.

The successful candidate will back up the QA Manager, lead quality initiatives, review SOPs and change records, and ensure compliance with GMP, FDA guidelines, and EHS requirements. Bilingual English/Spanish preferred.

Qualifications

• Bachelor's degree in biotechnology, biology, chemistry, or engineering.
• Four years of QA experience in pharma/biotech.
• Fluency in English and Spanish.
• Knowledge of GMP, safety regulations, investigations, and risk management.

Responsibilities

• Support manufacturing operations to meet quality goals and regulatory compliance.
• Back up QA Manager and lead quality initiatives.
• Investigate plant events and document CAPA in the system.
• Perform product impact analyses and place QA holds when needed.
• Approve SOPs, change management, and risk management documents.
• Coordinate with cross-functional teams on CAPA and regulatory requirements.
• Ensure EHS compliance and incident reporting.

Skills

Teamwork

Time management

Strong communication skills

Education

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

Tools

CAPA system

GMP documentation tools

Job description

Validation & Engineering Group, Inc. (V&E G) seeks a QA Specialist III to implement and maintain the Quality System and support manufacturing operations. The role involves impact assessments, investigations, CAPA, and ensuring product disposition in a regulated environment.

The successful candidate will back up the QA Manager, lead quality initiatives, review SOPs and change records, and ensure compliance with GMP, FDA guidelines, and EHS requirements. Bilingual English/Spanish preferred.