MES Quality Assurance Specialist — Digital Manufacturing

GlaxoSmithKline; Marietta (PA); On-site; USD 95,000 - 135,000; Full time

Job summary

GlaxoSmithKline in the United States seeks an experienced QA professional to provide operational QA oversight for MES workflows and electronic batch records within a regulated manufacturing environment.

You will review changes, approve master data updates, support CAPA investigations, and coach teams on GxP compliance, data integrity, and regulatory readiness to help ensure patient safety and product quality.

Qualifications

• Bachelor's degree in Life Sciences, Chemistry, or related field and relevant experience.
• Minimum 3 years in a regulated industry, preferably Quality Assurance.
• Hands-on MES implementation experience and familiarity with GMP/DSU concepts.

Responsibilities

• Provide operational QA oversight for MES workflows and electronic batch records.
• Ensure GMP compliance and readiness, review changes, and approve master data updates.
• Lead or support CAPA investigations, deviations, and validation documentation.
• Coach teams on data integrity, documentation quality, and regulatory expectations.

Skills

Data Integrity

Detail-Oriented

Digital Fluency

GxP Regulations

Influencing Without Authority

Lean Management

Pharmaceutical Regulatory Compliance

Problem Solving

Quality Assurance (QA)

Risk Awareness

Technical Writing

Education

Bachelor's degree in Life Sciences or related

Tools

MES

SAP

OsiPi

LIMS

Electronic Batch Records

Change Controls

Job description

GlaxoSmithKline in the United States seeks an experienced QA professional to provide operational QA oversight for MES workflows and electronic batch records within a regulated manufacturing environment.

You will review changes, approve master data updates, support CAPA investigations, and coach teams on GxP compliance, data integrity, and regulatory readiness to help ensure patient safety and product quality.