Scientist, QC Compliance, Cell Therapy

Scorpion Therapeutics; Bothell (WA); On-site; USD 140,000 - 200,000; Full time

Job summary

Scorpion Therapeutics is seeking a Lead QC Compliance professional to oversee deviations, investigations, CAPAs, change controls, and process improvements in a cell therapy environment. The role requires a strong background in cGMP, quality systems, and technical writing, with extensive experience in QC labs and investigation work.

The successful candidate will author deviation reports, conduct root cause analyses, and mentor team members while ensuring timely closure of investigations and

Qualifications

• Bachelor's in science/engineering required.
• 6+ years in biopharma QC labs with at least 2 years in investigation.
• Strong knowledge of cGMP and quality systems; technical writing skills required.

Responsibilities

• Author and oversee QC deviation reports.
• Conduct root cause analysis.
• Ensure timely closure of investigations.
• Generate KPIs.
• Report escalation risks.
• Support document revisions.
• Mentor colleagues and represent department during inspections.

Skills

QC experience

GMP knowledge

Technical writing

Education

Bachelor's in science/engineering

Job description

Role

Lead QC compliance for cell therapy manufacturing, specializing in deviations, investigations, CAPAs, change controls, and process improvements.

Responsibilities

• author and oversee QC deviation reports
• conduct root cause analysis
• ensure timely closure of investigations
• generate KPIs
• report escalation risks
• support document revisions
• mentor colleagues and represent department during inspections

Requirements

• Bachelor's in science/engineering
• 6+ years in biopharma QC labs, with at least 2 years in investigation
• strong knowledge of cGMP, quality systems, and technical writing

Preferred

• experience with cell therapy analytical/microbiological testing
• investigations
• root cause analysis techniques

High-Value

• focus on cell therapy modalities
• investigations in GMP manufacturing
• cross-functional collaboration
• compliance with global regulatory standards
• representing QC in inspections

WorkSetup

not specified, but role involves laboratory and compliance activities.