Senior QA Specialist - GMP, Validation & Compliance Lead

Xtalks; Carolina (NC); On-site; USD 70,000 - 100,000; Full time

Job summary

Validation & Engineering Group, Inc. is seeking a Specialist QA to support QA programs with minimal supervision. The role involves reviewing and approving product MPs, batch records, change controls, CAPA, and site audits, while collaborating with Manufacturing, Engineering, and Process Development to uphold GMP and GDP standards.

Bilingual English/Spanish is preferred. Strong project management and data trending skills are valued, with extended hours and occasional weekends possible.

Qualifications

• Experience with GMP manufacturing and QA review of change controls, deviations, CAPAs, protocols, reports.
• Experience supporting packaging/inspection operations and regulatory interactions.
• Bilingual English/Spanish communication preferred.

Responsibilities

• Review and approve product MPs.
• Approve validation protocols/reports for manufacturing processes.
• Lead site audits and investigations.
• Own site quality program procedures.
• Review and approve risk assessments, CAPAs, and change controls.
• Provide lot disposition and authorize lots for shipment.

Skills

GMP knowledge

QA review

Project management

Cross-functional collaboration

Bilingual English/Spanish

Strong communication

Data trending

Education

Doctorate or Masters + related exp

Bachelors + related exp

Associates + related exp

High school/GED + 10 years

Tools

Electronic quality systems

Job description

Validation & Engineering Group, Inc. is seeking a Specialist QA to support QA programs with minimal supervision. The role involves reviewing and approving product MPs, batch records, change controls, CAPA, and site audits, while collaborating with Manufacturing, Engineering, and Process Development to uphold GMP and GDP standards.

Bilingual English/Spanish is preferred. Strong project management and data trending skills are valued, with extended hours and occasional weekends possible.