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.