QA Specialist III - Analytical; 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.

• 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, Track Wise).
• 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.

• 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.