Sr. Specialist, Quality Assurance

Scorpion Therapeutics; Newark (CA); Hybrid; USD 120,000 - 170,000; Full time

Job summary

Scorpion Therapeutics seeks a Senior Specialist, Quality Assurance, to provide hands-on QA oversight within the Quality Systems team for biologic drug manufacturing. You will ensure regulatory compliance and lead quality activities across records, investigations, and CAPAs.

Responsibilities include coordinating change controls, deviations, and audits, and guiding validation and qualification efforts for facilities, equipment, and computerized systems using risk-based methods.

Qualifications

• Bachelor's degree in Biology, Chemistry, or related science.
• 6+ years of industry experience, including at least 4 years in QA.
• Strong knowledge of 21 CFR Parts 210-211, Eudralex Volume 4, ICH guidelines.
• Experience with aseptic processes and biologics preferred.

Responsibilities

• ensure compliance with GxP and regulatory standards
• coordinate and track quality records such as change controls, deviations, CAPAs, and investigations
• oversee validation and qualification activities for Facilities, Utility Systems, Equipment, Analytical Instruments, and Computerized Systems using risk-based approaches
• support Data Integrity Program and quality metrics development
• assist in audits and inspections, and contribute to continuous improvement of quality systems

Skills

GxP knowledge

Regulatory compliance

Quality oversight

Education

Bachelor's degree in Biology, Chemistry, or related science

Job description

Role

Senior Specialist, Quality Assurance, providing hands‑on QA oversight within the Quality Systems team for biologic drug manufacturing.

Responsibilities

• ensure compliance with GxP and regulatory standards
• coordinate and track quality records such as change controls, deviations, CAPAs, and investigations
• oversee validation and qualification activities for Facilities, Utility Systems, Equipment, Analytical Instruments, and Computerized Systems using risk-based approaches
• support Data Integrity Program and quality metrics development
• assist in audits and inspections, and contribute to continuous improvement of quality systems

Requirements

• Bachelor's degree in Biology, Chemistry, or related science
• 6+ years of industry experience, including at least 4 years in QA
• strong knowledge of 21 CFR Parts 210-211, Eudralex Volume 4, ICH guidelines
• experience with aseptic processes and biologics preferred

Key Technical Areas

• biologics
• GxP facilities
• Utilities
• Equipment
• Analytical Instruments
• Computerized Systems
• Data Integrity
• biologics manufacturing
• regulatory compliance (US and international cGMP)

Collaboration

• cross-functional with Quality Control
• Manufacturing
• Facilities
• IT
• Supply Chain
• Regulatory Affairs

Work Setup

hybrid Newark, CA (3 days/week in-office); moderate travel not specified.