MES QA Lead - GMP & Digital Manufacturing

Scorpion Therapeutics; Marietta (PA); On-site; USD 110,000 - 155,000; Full time

Job summary

Scorpion Therapeutics is seeking an experienced QA professional to provide independent oversight of MES/workflow integrity in gXp/GMP environments. You will validate and review MES data, change controls, and validation documents while driving CAPA and root-cause analysis across systems.

The role requires 3+ years in regulated QA, MES implementation experience, and strong knowledge of GMP and FDA guidelines.

Qualifications

• Bachelor’s degree in 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.

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.

Skills

GxP QA

GMP compliance

DMAIC RCA

CAPA management

Cross-functional collaboration

Education

Bachelor's degree in Life Sciences

Chemical Engineering

Tools

SAP

OSI PI

LIMS

Job description

Scorpion Therapeutics is seeking an experienced QA professional to provide independent oversight of MES/workflow integrity in gXp/GMP environments. You will validate and review MES data, change controls, and validation documents while driving CAPA and root-cause analysis across systems.

The role requires 3+ years in regulated QA, MES implementation experience, and strong knowledge of GMP and FDA guidelines.