QA MES Specialist

GSK•Marietta, PA

1d•Onsite

About The Position

GSK manufactures and supplies reliable, high-quality medicines and vaccines globally, with a network of 37 manufacturing sites. The company delivered 1.7 billion packs of medicines and 409 million vaccine doses in 2024, aiming to positively impact the health of millions. Technology, including smart manufacturing technologies like robotics, digital solutions, and artificial intelligence, is crucial for increasing the speed, quality, and scale of product supply. The company seeks talent to help make more complex products and harness these technologies. This role involves leading quality activities for Manufacturing Execution Systems (MES) and related digital quality tools. The specialist will collaborate with manufacturing, engineering, IT, validation, and quality teams to ensure MES supports compliant production, accurate data, and inspection readiness. The company values clear problem-solving, practical coaching, and continuous learning, offering growth and a real impact on product quality, aligning with its mission to unite science, technology, and talent to get ahead of disease.

Requirements

Bachelors degree in a technical, scientific, or quality-related field, or equivalent experience.
2+ years experience in quality, manufacturing, or digital systems within a regulated life sciences environment.
Experience with MES, electronic batch records, or other manufacturing execution or electronic quality systems.
Experience supporting change control, deviations, CAPA, or document management in a regulated environment.

Nice To Haves

Bachelor’s degree in engineering, life sciences, information systems, or a related field.
Experience with MES implementation, configuration, or validation in pharma or biotech.
Understanding of DQ/IQ/OQ/PQ or equivalent validation lifecycle and how it ties to quality systems.
Experience with electronic document management systems or quality management software.
Formal training in root cause analysis methods or investigation techniques.
Ability to coach and influence operational teams and to present technical information clearly.
Strong written and verbal communication skills and the ability to work across functions.
Practical knowledge of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP), including data integrity principles.

Responsibilities

Lead MES quality activities including system configuration reviews, electronic batch record checks, and system change control support.
Review MES-generated records and reports to confirm completeness, data integrity, and compliance with procedures.
Support investigations of deviations linked to MES or digital systems.
Perform root cause analysis and track corrective actions.
Partner with validation and IT to ensure MES changes link to DQ/IQ/OQ/PQ or equivalent validation steps and documentation.
Coach manufacturing and lab teams on good documentation practices, electronic record keeping, and system use on the shop floor.
Maintain inspection-ready MES records and contribute to quality KPI trending and continuous improvement initiatives.
Support readiness for internal and external audits, provide clear documentation and act as a subject matter contributor during inspections.
Manage supplier and third-party quality expectations for MES vendors and integrators, ensuring timely resolution of issues.