Quality Assurance Specialist

Job overview

The Quality Assurance Specialist role is onsite in the listed location of 00987, PR. Compensation is not specified. Validation & Engineering Group provides laboratory, compliance, computer, engineering, project management, and validation services to regulated industries. The specialist supports the Quality Assurance program by reviewing and approving quality records, leading investigations and audits, maintaining site procedures, and supporting compliant manufacturing and product release activities.

What you'll do

• Review and approve product MPs, process validation protocols and reports, environmental characterization reports, planned incidents, work orders, EMS/BMS alarms, risk assessments, change controls, nonconformance investigations, and CAPA records
• participate in incident triage and NPI teams
• release sanitary utility systems
• lead investigations and site audits
• own site quality procedures
• support automation, facilities, and environmental programs
• provide lot disposition and authorize lots for shipment.

What we're looking for

Skills & competencies

quality assurance specialist

validation & engineering group

puerto rico

full-time

quality assurance

gmp

process validation

capa

change controls

site audits

quality systems

lot disposition

pharmaceutical manufacturing

Work arrangement

• Weekend coverage required

Why this role

Education and experience alternatives range from a doctorate or master’s plus two years of related experience to high school/GED plus ten years. GMP manufacturing quality experience is preferred; extended hours and possible weekends or holidays may be required.

About the employer

Validation & Engineering Group, Inc is hiring for this role. Industry: Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology). Sector: 54.