Quality Assurance Specialist

AI-Enabled Quality Systems | Biotech / GMP Environment Join a next-generation biotech organization redefining Quality Assurance through AI-enabled knowledge systems. We are seeking a QA Specialist to support and strengthen our GxP quality framework while leveraging PDAOAI, our proprietary AI platform that transforms static SOP libraries into functional, queryable, decision-support systems. What You’ll Do Own and maintain GMP / GxP SOPs, policies, and controlled documents across QA, QC, Manufacturing, and Clinical operations. Use PDAOAI to interrogate and cross‑reference SOPs, deviations, CAPAs, and training records. Identify inconsistencies, gaps, and misalignment across the SOP corpus. Translate regulatory guidance into actionable, harmonized procedures. Support deviation investigations, CAPAs, change controls, and risk assessments. Participate in internal audits, vendor audits, and regulatory inspections. Ensure SOPs are not just compliant but operationally executable and inspection‑ready. Collaborate cross‑functionally with CMC, Clinical, Regulatory, and Operations teams. What Makes This Role Different You will not be maintaining static PDFs. You will functionalize the SOP corpus—turning procedures into living, AI‑assisted quality assets. You will help define how AI augments QA decision‑making, inspection readiness, and continuous improvement. You will work in a culture where Quality is strategic, not administrative. What We’re Looking For Bachelor’s degree in Life Sciences, Chemistry, Engineering, or related field. 3+ years of QA experience in a GMP / GxP‑regulated environment (biotech, pharma, CDMO, or clinical trials). Strong working knowledge of SOP lifecycle management; deviations, CAPAs, change control; FDA, EMA, ICH, and Annex 1 expectations (as applicable); comfort working with digital systems, structured data, and AI‑assisted tools. Detail‑oriented, systems‑thinking mindset with strong documentation skills. Prior experience with QMS platforms (Veeva, MasterControl, TrackWise, etc.) is a plus. Why Join Us Work with a cutting‑edge AI platform (PDAOAI) purpose‑built for regulated environments. Influence how Quality evolves in the age of AI. High‑impact role with visibility across R&D, CMC, and Clinical programs. Collaborative, science‑driven culture with strong executive engagement. #J-18808-Ljbffr