Engineer I, Quality Engineering (Analytical Method Validation)

Scorpion Therapeutics; Madison (WI); On-site; USD 110,000 - 150,000; Full time

Job summary

Scorpion Therapeutics in Madison, WI is seeking a Senior Quality Assurance specialist to support commercialization programs with a focus on analytical method verification/validation in GMP manufacturing.

You will lead and review validation strategies, serve as SME on method validation, mentor QA team members, and collaborate across departments to ensure compliance and data integrity, while supporting audits and maintaining quality systems.

Qualifications

• Bachelor's in science with 8+ years in cGMP manufacturing.
• Expertise in method validation.
• Knowledge of GMP regulations (ICH Q2, Q7, 21CFR Part 210/211).
• Strong organizational and communication skills.
• Experience with electronic document management systems (preferred).

Responsibilities

• lead and review validation strategies
• review and approve validation documentation
• serve as SME on method validation
• mentor QA team members
• assess validation changes/deviations
• support audits
• contribute to maintaining quality systems supporting GMP
• work across departments to ensure compliance and data integrity

Skills

Method validation

Organizational skills

Communication skills

GMP knowledge

Education

Bachelor's in science

Tools

MS Office

Job description

Role:

Senior Quality Assurance specialist supporting commercialization programs with a focus on analytical method verification/validation in GMP manufacturing.

Responsibilities:

• lead and review validation strategies
• review and approve validation documentation
• serve as SME on method validation
• mentor QA team members
• assess validation changes/deviations
• support audits
• contribute to maintaining quality systems supporting GMP
• work across departments to ensure compliance and data integrity

Requirements:

• Bachelor’s in science with 8+ years experience in cGMP-regulated manufacturing
• expertise in method validation
• knowledge of GMP regulations (ICH Q2, Q7, 21CFR Part 210/211)
• strong organizational and communication skills
• proficient in MS Office

Preferred:

• experience with electronic document management systems

High-Value:

• focus on analytical method validation for biologics or small molecules
• GMP compliance
• validation documentation
• cross-functional collaboration

WorkSetup:

not specified; based in Wisconsin with a focus on supporting commercial manufacturing.