QA Specialist III - Analytical (Small Molecule)

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. #J-18808-Ljbffr Scorpion Therapeutics