Quality Assurance & MES Compliance Specialist

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

Job summary

GSK in Marietta, PA seeks an experienced MES Quality Assurance professional to ensure adherence to cGxP standards through independent oversight of MES processes and QA activities. You will collaborate with manufacturing, engineering, IT and quality teams to maintain compliant, trustworthy data and drive continuous improvement.

The role offers hands-on learning, clear career growth, and alignment with our mission to unite science, technology and talent to get ahead of disease together.

Qualifications

• Bachelor’s degree in Life Sciences, Biology, Chemical Engineering or equivalent with technical depth
• Minimum 3 years' experience in a regulated industry, preferably Quality Assurance
• Prior MES implementation experience required
• Understanding of pharmaceutical facilities, equipment and systems to apply knowledge daily
• Experience with GMPs, FDA/regulatory compliance, validation principles and data integrity
• DMAIC root cause analysis training and experience
• 1+ year hands-on experience with GMP and GDP practices

Responsibilities

• Provide operational QA oversight for MES workflows, electronic batch records, and system-controlled manufacturing steps.
• Ensure GMP compliance and readiness for inspections across quality, safety and environmental regulations.
• Review changes to master data, URS and design documents and validate impact on MES/QA processes.
• Approve validation forms, deviation investigations, CAPA plans, logbooks and PQRs.
• Coach teams on procedures, data integrity and compliance; promote a “Quality Starts With Me” mindset.
• Lead investigations for deviations and data anomalies; perform root cause analysis and CAPA follow-up.
• Support inspections, audits, and regulatory inquiries related to computerized systems.
• Monitor MES quality KPIs and drive process or system improvements.

Skills

Data Integrity

Detail Oriented

Digital Fluency

GxP Regulations

Influencing Without Authority

Lean Management

Pharma Regulatory Compliance

Problem Solving

Quality Assurance

Risk Awareness

Technical Writing

Education

Bachelor's degree in Life Sciences

Bachelor's degree in Biology

Bachelor's degree in Chemical Engineering

Tools

LIMS

Electronic Batch Records

Job description

GSK in Marietta, PA seeks an experienced MES Quality Assurance professional to ensure adherence to cGxP standards through independent oversight of MES processes and QA activities. You will collaborate with manufacturing, engineering, IT and quality teams to maintain compliant, trustworthy data and drive continuous improvement.

The role offers hands-on learning, clear career growth, and alignment with our mission to unite science, technology and talent to get ahead of disease together.