Quality Control Specialist - MES
GSK
August 25, 2026
On-site
Marietta, PA
Operations
Position Summary:
Provide independent operational quality assurance oversight of GxP processes to ensure adherence to cGxP/GMP and improve effectiveness of quality in preventing/identifying/addressing quality issues. Support Operational MES-related design, implementation, and performance management; ensure MES activities for drug product manufacturing are compliant and data is trustworthy.
Responsibilities:
- Provide QA oversight for MES workflows, electronic batch records, and system-controlled manufacturing steps.
- Ensure GMP compliance (validation, quality, safety, environmental) and maintain inspection readiness.
- Review and approve QS change impact and updates to master data (equipment spec file, sMBR, workstations/workcenters) and PI/Main-PI/Sub-PI design/validation (incl. SAP and OsiPi integration).
- Approve validation forms, DI/business continuity risk assessments, audit trail reviews.
- Develop/approve MES SOPs and child documents.
- Review/deviations/CAPA, logbooks, PQRs, customer complaint investigations, change controls, and validation documents affecting MES/digital records.
- Coach for “Quality Starts With Me,” conduct walkthroughs, lead/support investigations (deviations, system incidents, data anomalies) with root cause analysis and CAPA.
- Support inspections/internal audits and regulatory questions; monitor MES quality KPIs and recommend improvements.
Basic Qualifications:
- Bachelor’s degree (Life Sciences/Biology/Chemical Engineering; other disciplines acceptable with sufficient technical depth).
- 3+ years in regulated industry (preferably QA).
- Prior MES implementation experience.
- GMP, NIH Guidelines, FDA/other regulatory compliance; validation principles; aseptic processing; quality systems.
- DMAIC root cause analysis experience; 1+ year hands-on GMP and good documentation practices.
Preferred Qualifications:
- Biologics manufacturing experience.
- Familiarity with 21 CFR Part 11 / Annex 11; system validation (IQ/OQ/PQ) or computerized system lifecycle.
- Experience with LIMS/electronic batch records/digital manufacturing solutions.
- Strong communication, coaching, cross-functional influence, prioritization, and CAPA/root-cause expertise.
Provide independent operational quality assurance oversight of GxP processes to ensure adherence to cGxP/GMP and improve effectiveness of quality in preventing/identifying/addressing quality issues. Support Operational MES-related design, implementation, and performance management; ensure MES activities for drug product manufacturing are compliant and data is trustworthy.
Responsibilities:
- Provide QA oversight for MES workflows, electronic batch records, and system-controlled manufacturing steps.
- Ensure GMP compliance (validation, quality, safety, environmental) and maintain inspection readiness.
- Review and approve QS change impact and updates to master data (equipment spec file, sMBR, workstations/workcenters) and PI/Main-PI/Sub-PI design/validation (incl. SAP and OsiPi integration).
- Approve validation forms, DI/business continuity risk assessments, audit trail reviews.
- Develop/approve MES SOPs and child documents.
- Review/deviations/CAPA, logbooks, PQRs, customer complaint investigations, change controls, and validation documents affecting MES/digital records.
- Coach for “Quality Starts With Me,” conduct walkthroughs, lead/support investigations (deviations, system incidents, data anomalies) with root cause analysis and CAPA.
- Support inspections/internal audits and regulatory questions; monitor MES quality KPIs and recommend improvements.
Basic Qualifications:
- Bachelor’s degree (Life Sciences/Biology/Chemical Engineering; other disciplines acceptable with sufficient technical depth).
- 3+ years in regulated industry (preferably QA).
- Prior MES implementation experience.
- GMP, NIH Guidelines, FDA/other regulatory compliance; validation principles; aseptic processing; quality systems.
- DMAIC root cause analysis experience; 1+ year hands-on GMP and good documentation practices.
Preferred Qualifications:
- Biologics manufacturing experience.
- Familiarity with 21 CFR Part 11 / Annex 11; system validation (IQ/OQ/PQ) or computerized system lifecycle.
- Experience with LIMS/electronic batch records/digital manufacturing solutions.
- Strong communication, coaching, cross-functional influence, prioritization, and CAPA/root-cause expertise.