Operational Quality Specialist

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

Position Summary:
You will provide operational quality oversight at a United States manufacturing site. Work with production, laboratories, engineering, and quality teams to keep processes compliant, safe, and reliable; maintain adherence to cGxP standards; provide independent oversight of GxP processes; maintain batch record review/approval, quality decision-making, and quality escalations; and liaise with QA Systems, QA Compliance, and QA Product Release (QAPR).

Responsibilities

• Ensure GMP processes and personnel meet current GMP and applicable regulatory requirements; maintain inspection readiness.
• Provide shopfloor oversight; first contact for initial quality issue management and quality 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 (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 associated CAPA plans; review documentation including procedural revisions, logbooks, PQRs, complaint investigations, change controls, and validation documents.
• 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 and corrective/preventive actions.

Basic Qualifications

• Bachelor's degree in biology/chemical engineering/life sciences (or other discipline with technical depth).
• 2+ years in regulated industry; strong QA background; biologics manufacturing strongly preferred; experience in pharma facilities/equipment/quality systems.
• 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.

Preferred Qualifications

• Biologics/pharma experience with deviations, CAPA, change control, and validation; root cause analysis methods (DMAIC or similar).
• Inspection readiness and regulatory expectations; ability to influence teams and coach on quality behaviors; fast‑paced prioritization.
• Strong communication and interpersonal skills; foster "Quality Starts With Me" culture; continuous improvement.