QA Specialist II — GMP Compliance & Release (Biotech)

Scorpion Therapeutics; Madison (WI); On-site; USD 70,000 - 85,000; Full time

Benefits offered by this job

Competitive salaries and an excellent

Excellent benefits package

Job summary

Scorpion Therapeutics in Madison, WI is seeking a Quality Assurance professional to support GMP/compliance activities across development and manufacturing. You will review batch records, material data, and deviation investigations, maintain EDMS documentation, and ensure data integrity while working with cross-functional teams.

Ideal candidates have 3+ years in biotech/pharma QA, strong communication skills, and the ability to work independently in a fast-paced environment.

Qualifications

• Bachelor-level science degree and related experience in biotech/pharma QA/regulatory
• Knowledge of GMP, GCP, GLP; familiarity with ICH/FDA guidance
• Strong communication skills and ability to write clearly
• Ability to work independently with minimal supervision and manage priorities in a fast-paced environment
• Attention to detail and organizational skills

Responsibilities

• Gather and review QA documentation with minimal supervision.
• Review batch records, forms, and testing data.
• Release raw materials and perform room releases as needed.
• Assist investigations and deviations; organize project docs.
• Maintain GMP/GCP/GLP compliance and EDMS records.
• Produce controlled forms and ensure data integrity.

Skills

GMP knowledge

Documentation review

Compliance

Independent work

Interpersonal skills

Written communication

Education

BS/BA in chemistry, biology, biochemistry

Tools

MS Word

Excel

Smartsheet

EDMS

Job description

Scorpion Therapeutics in Madison, WI is seeking a Quality Assurance professional to support GMP/compliance activities across development and manufacturing. You will review batch records, material data, and deviation investigations, maintain EDMS documentation, and ensure data integrity while working with cross-functional teams.

Ideal candidates have 3+ years in biotech/pharma QA, strong communication skills, and the ability to work independently in a fast-paced environment.