QA MES Specialist
GSK
1 month ago
On-site
Marietta, PA
Operations
Position Summary
You will lead quality activities for Manufacturing Execution Systems (MES) and related digital quality tools. You will partner with manufacturing, engineering, IT, validation, and quality teams to ensure MES supports compliant production, accurate data, and inspection readiness.
Responsibilities
- Lead MES quality activities (system configuration reviews, electronic batch record checks, system change control support).
- Review MES-generated records and reports for completeness, data integrity, and procedure compliance.
- Support investigations of MES/digital system-linked deviations; 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; contribute to quality KPI trending and continuous improvement.
- Support internal/external audits with clear documentation and act as a subject matter contributor.
- Manage supplier/third-party quality expectations for MES vendors and integrators.
Required Qualifications
- Bachelor’s degree in a technical, scientific, or quality-related field, or equivalent experience.
- 2+ years’ experience in quality, manufacturing, or digital systems in a regulated life sciences environment.
- Experience with MES, electronic batch records, or other manufacturing execution/electronic quality systems.
- Experience with change control, deviations, CAPA, or document management in a regulated environment.
Preferred Qualifications
- Engineering/life sciences/IS degree; MES implementation/configuration/validation in pharma/biotech.
- Understanding of DQ/IQ/OQ/PQ validation lifecycle.
- Experience with electronic document management/quality software; root cause analysis training.
- Knowledge of GMP/GDP and data integrity principles; strong communication and cross-functional influence.
Work Arrangement
On-site; minimum 4 days weekly for hands-on MES support, validation activities, and shop-floor coaching.
How to apply
Apply and explain how your skills and experience match the role.
You will lead quality activities for Manufacturing Execution Systems (MES) and related digital quality tools. You will partner with manufacturing, engineering, IT, validation, and quality teams to ensure MES supports compliant production, accurate data, and inspection readiness.
Responsibilities
- Lead MES quality activities (system configuration reviews, electronic batch record checks, system change control support).
- Review MES-generated records and reports for completeness, data integrity, and procedure compliance.
- Support investigations of MES/digital system-linked deviations; 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; contribute to quality KPI trending and continuous improvement.
- Support internal/external audits with clear documentation and act as a subject matter contributor.
- Manage supplier/third-party quality expectations for MES vendors and integrators.
Required Qualifications
- Bachelor’s degree in a technical, scientific, or quality-related field, or equivalent experience.
- 2+ years’ experience in quality, manufacturing, or digital systems in a regulated life sciences environment.
- Experience with MES, electronic batch records, or other manufacturing execution/electronic quality systems.
- Experience with change control, deviations, CAPA, or document management in a regulated environment.
Preferred Qualifications
- Engineering/life sciences/IS degree; MES implementation/configuration/validation in pharma/biotech.
- Understanding of DQ/IQ/OQ/PQ validation lifecycle.
- Experience with electronic document management/quality software; root cause analysis training.
- Knowledge of GMP/GDP and data integrity principles; strong communication and cross-functional influence.
Work Arrangement
On-site; minimum 4 days weekly for hands-on MES support, validation activities, and shop-floor coaching.
How to apply
Apply and explain how your skills and experience match the role.