Senior Quality Specialist, Technical

Scorpion Therapeutics; California (MO); Hybrid; USD 110,000 - 150,000; Full time

Job summary

Scorpion Therapeutics is seeking a Senior Specialist, Quality Assurance Technical to support qualification and validation for solid oral and biologic products, ensuring compliance with regulatory standards.

The role requires reviewing technical documents, data review, and collaboration across functions. Remote in San Diego with 10% travel; some face-to-face work is expected, and experience with Veeva QMS is preferred.

Qualifications

• Bachelor’s degree in life sciences (Chemistry, Biology, or related field preferred).
• 5+ years of GMP Quality Assurance, Validation/Qualification in biotech/pharma.
• Familiarity with electronic QMS systems like Veeva.
• Broad knowledge of cGMPs (CFR/ICH) and international guidelines.

Responsibilities

• Review and approve technical documents such as validation protocols, change controls, investigations, and stability reports.
• Support data review and regulatory discrepancy checks.
• Develop knowledge of validation requirements, manufacturing, and analytical testing.
• Assist with technical projects and cross-functional collaboration.

Skills

GMP Quality Assurance

Validation/Qualification

QMS familiarity

Regulatory knowledge CFR/ICH

Education

Bachelor's in life sciences

Tools

Veeva QMS

Job description

Role: Senior Specialist, Quality Assurance Technical, supporting qualification and validation activities for solid oral and biologic products, ensuring compliance with regulatory standards.

Responsibilities:

• review and approve technical documents such as validation protocols, change controls, investigations, and stability reports
• support data review and regulatory discrepancy checks
• develop knowledge of validation requirements, manufacturing, and analytical testing
• assist with technical projects and cross-functional collaboration

Requirements:

• Bachelor's in life sciences (Chemistry, Biology, Chemical Engineering preferred)
• 5+ years in GMP Quality Assurance, Validation/Qualification in biotech/pharma
• familiarity with electronic QMS systems like Veeva
• broad knowledge of cGMPs (CFR/ICH) and international guidelines

High-Value:

solid oral and biologic products, GMP validation, technical documentation review, supplier change management, stability, and investigations.

WorkSetup:

remote in San Diego with 10% domestic and international travel; face-to-face work expected.