<p>The Position</p> <p>Provides quality oversight for GLP/GCLP-compliant bioanalytical and biomarker activities. The QA Specialist II is responsible for conducting audits, collaborating with stakeholders, and ensuring that studies are compliant with regulatory standards.</p> <p>Responsibilities:</p> <ul> <li>Independently plan, conduct, and report study-specific audits, including method validation and sample analysis phases. </li><li>Review and approve study protocols, validation reports, and analytical plans for QA compliance. </li><li>Audit raw data (chromatography, LIMS) for integrity and regulatory alignment. </li><li>Support regulatory readiness efforts, including preparing responses to audit findings. </li><li>Manage QA activities across assigned clinical and nonclinical studies. </li><li>Lead non-conformance investigations and draft comprehensive CAPAs. </li><li>Proactively identify areas for quality improvement and update audit tools or SOPs accordingly. </li><li>Serve as QA liaison for assigned projects and ensure proper documentation in systems like LIMS or Vault. </li><li>May mentor QA Specialist I personnel and contribute to their onboarding. </li></ul> <p>Requirements:</p> <ul> <li>Bachelor's or Master's degree in a scientific field. </li><li>2 years of GLP/GCLP QA experience in pharma or CRO settings. </li><li>Knowledge of OECD GLP, FDA/EMA regulations, ICH M10, and 21 CFR Part 11. </li><li>Working experience auditing HPLC, LC-MS/MS, and ELISA. </li><li>Excellent communication skills and experience drafting audit reports. </li></ul> <p>Preferred:</p> <ul> <li>ASQ Certified Quality Auditor (CQA) or equivalent certification. </li><li>Experience supporting biologics, gene therapies, or biomarkers in oncology or rare disease programs. </li><li>Familiarity with electronic systems including Veeva Vault QMS, LIMS, and eTMF. </li></ul>