Quality Control Specialist - MES

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

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.