QA Specialist III - Analytical (Small Molecule)

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

Responsibilities

• Review and approve analytical quality documentation supporting regulatory submissions (INDs, NDAs, amendments, supplements, annual reports).
• Review and approve batch-related analytical documentation and support product disposition for clinical, registration, commercial, and stability batches.
• Evaluate analytical records (raw data, lab notebooks, reports, CoAs/CoTs, supporting documentation) for accuracy, completeness, and GMP compliance.
• Review analytical methods, method validation protocols/reports, method transfers, and associated change controls.
• Review specifications, specification justifications, and specification revisions.
• Review document changes (SOPs, specifications, analytical methods, master batch records) for GMP compliance.
• Support Regulatory Affairs by reviewing manufacturing process, analytical method, and specification changes impacting submissions.
• Review Quality System records (deviations/OOS/OOT, lab investigations, CAPAs, change controls, risk assessments) for timely completion and compliance.
• Review and approve stability protocols/reports and stability data; evaluate internal/external stability trend data.
• Collaborate with CMOs, contract laboratories, Manufacturing, Analytical Development, and Technical Operations to resolve quality issues.
• Participate in continuous improvement initiatives to enhance analytical quality processes and the Quality System.

Qualifications

• BS in Chemistry, Pharmaceutical Sciences, Biology, or related field + 5+ years in analytical development, manufacturing, or QA in biotechnology (or equivalent).
• 3+ years experience in a GMP environment.
• Preferred: regulatory submission experience (INDs/NDAs/amendments/supplements), CMO/contract laboratory experience, and use of eQMS (Veeva Vault, TrackWise).
• Experience reviewing analytical methods/validation/transfer, change controls, and stability documentation.
• Working knowledge of GMP regulations/guidance (FDA, ICH, USP/NF).
• Experience with drug substance and drug product analytical testing, including troubleshooting.
• Strong written/verbal communication; organizational/time-management; manage multiple priorities; attention to detail and sound judgment.
• Proficiency with Microsoft 365, SharePoint, and Veeva.

Benefits

• 401(k) with generous employer match; 12 weeks paid parental leave; up to 12 weeks living organ and bone marrow leave; health plans; life insurance and disability; flexible time off; annual Winter Holiday shutdown; at least 11 paid holidays.