QA Specialist: Validation, Audits & Compliance Lead

Veg Group; Juncos (PR); On-site; USD 65,000 - 95,000; Full time

Job summary

Validation & Engineering Group, Inc. seeks a Specialist QA to support the Quality Assurance program with minimal supervision. You will review and approve product MPs, process validation protocols, and environmental reports while leading investigations and site audits.

The role requires strong organizational and cross-functional collaboration skills, experience with GMP QA activities, and the ability to interact with regulatory bodies when needed. Weekend/extended hours may be required.

Qualifications

• Doctorate or Masters plus 2 years of related experience, or Bachelor's plus 4 years of related experience, or Associates plus 8 years of related experience.
• GMP manufacturing experience in QA, including review/approval of change controls, deviations, CAPAs, protocols, reports, and procedures.
• Bilingual English/Spanish communication skills preferred.

Responsibilities

• Review and approve product MPs.
• Approve process validation protocols and reports for manufacturing processes.
• Lead site audits.
• Own site quality program procedures.
• Review Risk Assessments.
• Support Automation activities.
• Review and approve EMS/BMS alarms.
• Approve NC investigations and CAPA records.
• Provide lot disposition and authorize lots for shipment.

Skills

Project management

Team leadership

Data analysis

Communication

Independent work

Education

Bachelor's degree in related field

Master's degree in related field

PhD

Job description

Validation & Engineering Group, Inc. seeks a Specialist QA to support the Quality Assurance program with minimal supervision. You will review and approve product MPs, process validation protocols, and environmental reports while leading investigations and site audits.

The role requires strong organizational and cross-functional collaboration skills, experience with GMP QA activities, and the ability to interact with regulatory bodies when needed. Weekend/extended hours may be required.