Lead QA Specialist, Validation & Compliance

Veg Group; Carolina (PR); Hybrid; USD 90,000 - 130,000; Full time

Job summary

Validation & Engineering Group, Inc. (V&EG) is seeking a Specialist QA to support the Quality Assurance program with minimal supervision at our facility. You will review and approve MPs, validation protocols, and incident triage decisions, and own QA procedures on site.

The role requires strong knowledge of GMP, GDP, and electronic quality systems, with bilingual English/Spanish preferred. Collaboration with Manufacturing, Engineering, and Process Development is essential, including weekend or

Qualifications

• Advanced degree with QA experience in GMP environments.
• Experience reviewing change controls, deviations, CAPAs, protocols, reports, and procedures.
• Bilingual English/Spanish communication preferred.
• Strong organizational and cross-functional leadership skills.
• Ability to interact with regulatory agencies.
• Independent work style with effective communication.

Responsibilities

• Review and approve product MPs.
• Approve process validation protocols and reports for manufacturing processes.
• Lead investigations and ensure corrective actions.
• Own site quality program procedures.
• Designee for QA manager on local CCRB.
• Support automation, facilities and environmental programs.
• Review and approve Work Orders and EMS/BMS alarms.
• Approve NC investigations and CAPA records.
• Approve change controls and disposition of lots for shipment.

Skills

GMP knowledge

QA review

Deviation handling

Process validation

Investigations

Regulatory interaction

Bilingual EN/ES

Education

Doctorate or Masters + 2 years of related experience

Bachelor + 4 years of related experience

Associates + 8 years of related experience

High school/GED + 10 years of related experience

Tools

Electronic quality systems

Job description

Validation & Engineering Group, Inc. (V&EG) is seeking a Specialist QA to support the Quality Assurance program with minimal supervision at our facility. You will review and approve MPs, validation protocols, and incident triage decisions, and own QA procedures on site.

The role requires strong knowledge of GMP, GDP, and electronic quality systems, with bilingual English/Spanish preferred. Collaboration with Manufacturing, Engineering, and Process Development is essential, including weekend or