QA Specialist – Validation & Compliance Leader

Veg Group; Carolina (PR); In loco; USD 70.000 - 100.000; Tempo pieno

Descrizione del lavoro

Validation & Engineering Group, Inc. seeks a Specialist QA to support the Quality Assurance program with minimal supervision.

Responsibilities include reviewing and approving MPs, process validation protocols, environmental characterization, and site audits. The role requires strong QA knowledge, cross-functional collaboration with Manufacturing, Engineering, and Process Development, and the ability to lead investigations.

Competenze

• Doctorate or Masters + 2 years of directly related experience or Bachelors + 4 years of directly related experience or Associates + 8 years of directly related experience.
• Preferred GMP manufacturing experience in Quality Assurance, including review and approval of change controls, deviations, CAPAs, protocols, reports, and procedures.
• Bilingual English/Spanish communication skills are preferred.

Mansioni

• Review and approve product MPs.
• Approve process validation protocols and reports for manufacturing processes.
• Release of sanitary utility systems.
• Lead site audits and investigations.
• Own site quality program procedures and QA on NPI teams.
• Review Risk Assessments and CAPA records.
• Provide lot disposition and authorize lots for shipment.

Conoscenze

GMP experience

Quality Assurance

Change controls

CAPA investigations

Regulatory liaison

Bilingual English/Spanish

Project management

Formazione

PhD or Masters

Bachelor's degree

High school/GED

Descrizione del lavoro

Validation & Engineering Group, Inc. seeks a Specialist QA to support the Quality Assurance program with minimal supervision.

Responsibilities include reviewing and approving MPs, process validation protocols, environmental characterization, and site audits. The role requires strong QA knowledge, cross-functional collaboration with Manufacturing, Engineering, and Process Development, and the ability to lead investigations.