Quality Assurance MES Specialist – GMP & Data Integrity

GSK; Marietta (GA); On-site; USD 90,000 - 130,000; Full time

Job summary

GSK in Marietta, GA is seeking an experienced QA professional to provide operational QA oversight for MES workflows, electronic batch records, and system-controlled manufacturing steps.

You will collaborate with manufacturing, engineering, IT and quality teams to ensure GMP compliance, data integrity and readiness for inspections. A strong background in GMP, FDA regulations, and MES validation is required; experience with DMAIC is preferred.

Qualifications

• Bachelor’s degree in Life Sciences or related field with relevant QA experience.
• Experience interpreting GMP/FDA guidance in a manufacturing environment.
• Hands-on MES validation and quality system experience.

Responsibilities

• Provide operational QA oversight for MES workflows and electronic batch records.
• Ensure GMP compliance and data integrity across manufacturing processes.
• Review changes to master data, URS, and validation documents with QA sign-off.
• Coach teams on procedures and lead root-cause analyses for deviations.

Skills

Data Integrity

GxP Regulations

Quality Assurance

Technical Writing

Education

Bachelor’s degree in Life Sciences

Tools

MES Systems

Job description

GSK in Marietta, GA is seeking an experienced QA professional to provide operational QA oversight for MES workflows, electronic batch records, and system-controlled manufacturing steps.

You will collaborate with manufacturing, engineering, IT and quality teams to ensure GMP compliance, data integrity and readiness for inspections. A strong background in GMP, FDA regulations, and MES validation is required; experience with DMAIC is preferred.