QA Specialist: Validation, Audits & CAPA Leader

Validation & Engineering Group, Inc.; Juncos (PR); On-site; USD 90,000 - 120,000; Full time

Job summary

Validation & Engineering Group, Inc. seeks a Specialist QA to support the Quality Assurance program under minimal supervision at our Puerto Rico facility.

The role involves ensuring compliance through review and approval of MPs, protocols, and CAPA records, and participating in investigations, audits, and change controls. Ideal candidates bring GMP manufacturing QA experience, cross-functional collaboration with Manufacturing, Engineering, and Process Development, and strong documentation

Qualifications

• PhD or Masters with related experience, or a Bachelor's with several years in QA.
• Bilingual English/Spanish communication skills are preferred.
• Project management, leadership, and cross-functional collaboration are desired.

Responsibilities

• Review and approve product MPs.
• Approve process validation protocols and reports.
• Lead investigations and site audits.
• Review Risk Assessments and CAPA records.
• Provide lot disposition and authorize lots for shipment.

Education

PhD or Masters in related field

Bachelor's in related field

High school / GED + 10 years experience

Job description

Validation & Engineering Group, Inc. seeks a Specialist QA to support the Quality Assurance program under minimal supervision at our Puerto Rico facility.

The role involves ensuring compliance through review and approval of MPs, protocols, and CAPA records, and participating in investigations, audits, and change controls. Ideal candidates bring GMP manufacturing QA experience, cross-functional collaboration with Manufacturing, Engineering, and Process Development, and strong documentation