Senior Analytical QA Specialist - Regulatory Submissions

Scorpion Therapeutics; Newark (CA); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

401(k) match

Paid parental leave

Health plans

Job summary

Scorpion Therapeutics is seeking an experienced QA professional to review analytical quality documentation supporting regulatory submissions and batch dispositions. The role emphasizes GMP compliance, method validation oversight, and collaboration with CMOs and laboratories.

The candidate will evaluate raw data, CoAs/CoTs, and change controls, ensuring accuracy and traceability across analytical records. Strong communication and multitasking are required.

Qualifications

• BS in Chemistry, Pharmaceutical Sciences, Biology, or related field; 5+ years in analytical development, manufacturing, or QA in biotechnology (or equivalent).
• 3+ years in GMP environment.
• Regulatory submission experience (INDs/NDAs/amendments/supplements) preferred; eQMS experience (Veeva Vault, TrackWise).

Responsibilities

• Review analytical quality documentation for regulatory submissions and batch dispositions.
• Evaluate analytical records for GMP compliance and accuracy.
• Review methods, validation, transfers, and change controls.
• Review specifications and specification revisions; ensure GMP compliance of document changes.
• Collaborate with CMOs and labs to resolve quality issues.
• Support Regulatory Affairs with process and specification changes.

Skills

Communication skills

Attention to detail

Time management

Multitasking

Judgment

Education

BS in Chemistry

Related field

Tools

Veeva Vault

TrackWise

Job description

Scorpion Therapeutics is seeking an experienced QA professional to review analytical quality documentation supporting regulatory submissions and batch dispositions. The role emphasizes GMP compliance, method validation oversight, and collaboration with CMOs and laboratories.

The candidate will evaluate raw data, CoAs/CoTs, and change controls, ensuring accuracy and traceability across analytical records. Strong communication and multitasking are required.