Quality Assurance Specialist

Job overview

The Quality Assurance Specialist role is onsite in Guaynabo, PR. Compensation is not specified. Validation & Engineering Group provides laboratory, compliance, computer, engineering, project management, and validation services to life-sciences and related industries. The specialist provides independent quality oversight for change control, qualification, and computer system validation activities. The role supports compliant, inspection-ready operations by reviewing records and evidence, coordinating program activities, identifying risks, and communicating status to management.

What you'll do

• Review and approve or reject assigned change control, qualification, and computer system validation records
• assess documentation, risk, traceability, and data integrity
• coordinate the Change Control Committee and track actions
• review lifecycle documents and executed protocols
• maintain dashboards and inspection-ready records
• report risks and status to management.

What we're looking for

Skills & competencies

quality assurance specialist

gmp

pharmaceutical quality

change control

qualification

computer system validation

csv

data integrity

guaynabo pr

validation & engineering group

Work arrangement

• Weekend coverage required

Why this role

Requires at least three years of quality assurance experience in a GMP-regulated life-sciences environment and direct experience with change control and qualification or computer system validation.

About the employer

Validation & Engineering Group, Inc is hiring for this role. Industry: Engineering Services. Sector: 54.