Senior QA Specialist: Process Validation & Compliance

Veg Group; Juncos (PR); On-site; USD 90,000 - 120,000; Full time

Job summary

Validation & Engineering Group, Inc. (V&EG) is seeking a talented Specialist QA to join our compliance-driven team in Puerto Rico.

You will review and approve MPs, validation protocols, CAPA records, change controls and QA documentation, while leading investigations and audits. Applicants should have a Bachelor’s degree plus four years of directly related experience, strong leadership, cross-functional collaboration, and solid knowledge of QA, QAL, validation and process development within

Qualifications

• Bachelor’s degree plus 4 years of directly related experience.
• Experience with regulatory audits and CAPA processes.
• Strong ability to lead cross-functional teams.
• Experience in QA, QAL, validation and process development.

Responsibilities

• Review and approve product MPs.
• Approve validation protocols and reports for manufacturing processes.
• Lead investigations.
• Lead site audits.
• Own site quality program procedures.
• Designee for QA manager on CCRB.
• Review Risk Assessments.
• Provide lot disposition and authorize lots for shipment.

Skills

Project management

Cross-functional leadership

Regulatory interaction

QA/QAL experience

Process validation

Data analysis

Education

Bachelor's degree + 4 years of directly related experience

Tools

Word processing

Presentation software

Database

Spreadsheet

Job description

Validation & Engineering Group, Inc. (V&EG) is seeking a talented Specialist QA to join our compliance-driven team in Puerto Rico.

You will review and approve MPs, validation protocols, CAPA records, change controls and QA documentation, while leading investigations and audits. Applicants should have a Bachelor’s degree plus four years of directly related experience, strong leadership, cross-functional collaboration, and solid knowledge of QA, QAL, validation and process development within