Lead Analytical QA Scientist – GMP & Data Integrity

Scorpion Therapeutics

Indianapolis (IN)

On-site

USD 110,000 - 170,000

Full time

5 days ago

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Job summary

Lilly Medicines Foundry in Indiana seeks a Sr. Principal Associate for Analytical Quality Assurance to provide quality oversight for laboratory activities, ensure data integrity, and support the quality management system for GMP testing and analytical development.

You will lead QA reviews of deviations, OOS investigations, and method verification/validation, collaborate with Lilly quality organizations, drive continuous improvement, and promote a strong quality culture in laboratory operations

Qualifications

Bachelor’s degree + minimum 5 years technical laboratory experience.
Pharmaceutical QA experience preferred.
Authorized to work in the United States full-time; no visa sponsorship.

Responsibilities

Provide quality oversight in Analytical testing: molecule/modality support, qualification of new contract labs, audit support, quality system ownership, lead analytical compliance projects, and review quality documentation (deviations, change records).
Provide quality oversight of method verification, qualification, and validation.
Ensure quality systems are in place and used; facilitate quality improvement and implementation of new quality standards.
Evaluate impact of incidents on material quality or data integrity.
Ensure investigations for deviations, stability failures, and OOS results; review/approve related documentation.
Perform QA review/approval/rejection of GMP documentation and ensure expert review.