GMP Quality Steward - Operations & Compliance

Scorpion Therapeutics; Marietta (PA); On-site; USD 90,000 - 120,000; Full time

Job summary

Scorpion Therapeutics in the United States is seeking an operational quality oversight professional at a manufacturing site. You will work with production, laboratories, engineering, and quality teams to ensure processes are compliant, safe, and reliable.

The role emphasizes adherence to cGxP standards, independent quality oversight of GxP processes, batch record review/approval, quality decisions, and escalation, with liaison to QA Systems, QA Compliance, and QA Product Release.

Qualifications

• 2+ years in regulated industry with strong QA background.
• 1+ years with GMPs and NIH/FDA/other regulatory compliance.
• Validation principles, aseptic processing, quality systems, and FDA regulations; DMAIC training; batch record/GMP documentation review.

Responsibilities

• Ensure GMP processes and personnel meet current GMP and regulatory requirements; maintain inspection readiness.
• Provide shopfloor oversight; first contact for initial quality issue management and escalations.
• Observe GMP activities in real time to proactively detect potential quality issues and enable timely interventions.
• Perform spot-checks across production and laboratory areas including production, testing, cleaning, maintenance.
• Review cGMP documentation/data for ALCOA+ data integrity and GDP; review and approve batch records and related documentation.
• Review/approve deviations and CAPA plans; review changes, logbooks, PQRs, investigations, change controls, and validation docs.
• Ensure GMPs, validation, quality, safety, and environmental regulations are met.
• Coach employees on compliance, procedure adherence, and patient safety impact.
• Support disposition/lot release and self-inspections/internal audits/inspection readiness.
• Review/approve GMP documentation updates (change controls, validation summaries); investigate quality issues and support root cause analysis.

Skills

QA background

GMP knowledge

Regulatory compliance

Quality systems

Education

Bachelor's degree in biology/chemical engineering/life sciences

Job description

Scorpion Therapeutics in the United States is seeking an operational quality oversight professional at a manufacturing site. You will work with production, laboratories, engineering, and quality teams to ensure processes are compliant, safe, and reliable.

The role emphasizes adherence to cGxP standards, independent quality oversight of GxP processes, batch record review/approval, quality decisions, and escalation, with liaison to QA Systems, QA Compliance, and QA Product Release.