GSK
Operational Quality Specialist - MES
USA - Pennsylvania - Marietta · On-site · Full-time · Posted Aug 26, 2026
- Experience
- Minimum 3 years in a regulated industry, preferably in Quality Assurance; prior MES implementation experience; at least 1 year of hands-on GMP and Good Documentation Practices experience.
- Education
- Bachelor’s degree in Life Sciences, Biology, or Chemical Engineering; a bachelor’s degree in another discipline may be acceptable with sufficient technical depth achieved from experience.
About the job
Provides operational quality assurance for manufacturing execution system (MES) activities, ensuring compliant manufacturing processes and reliable digital records for drug production.
What you'll do
- Oversee MES workflows, electronic batch records, validation, master data, and related quality documentation.
- Lead or support investigations, deviations, CAPA follow-up, change controls, and inspection readiness.
- Coach manufacturing teams on GMP, data integrity, and quality practices; monitor quality trends and recommend improvements.
What they ask for
- Bachelor’s degree in Life Sciences, Biology, or Chemical Engineering; another discipline may be acceptable with sufficient technical depth from experience.
- At least 3 years’ regulated-industry experience, preferably in Quality Assurance.
- Prior MES implementation experience and understanding of pharmaceutical facilities, equipment, and systems.
- At least 1 year of hands-on GMP and Good Documentation Practices experience; training and work experience in DMAIC root cause analysis.
Nice to have
- Biologics manufacturing experience.
- Familiarity with 21 CFR Part 11 or Annex 11, system validation (IQ/OQ/PQ), LIMS, electronic batch records, or other digital manufacturing solutions.
Tools
MES, SAP, OsiPi, LIMS, IQ/OQ/PQ, 21 CFR Part 11, Annex 11
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