Precision for Medicine - Quality Assurance Specialist III

• Bachelor’s Degree or Master Degree in Life Sciences, Pharmacy, Biology, Chemistry • 4 years of related experience in a life science GxP environment with CRO experience preferred • Hands-on experience with • ICH-GCP (E6 R2/R3) • FDA regulations (e.g., 21 CFR Part 11) • EMA / EU CTR / Annex 11 • GxP frameworks (GCP, GMP, GLP, GCLP) • Preferred certification • ASQ Certified Quality Auditor (CQA) • ISO 9001 / ISO 13485 Lead Auditor • GxP Lead Auditor certifications (e.g., CQI/IRCA) • Clinical QA certifications (e.g., CCQAP) • High attention to detail • Strong written and verbal communication • Ability to meet deadlines and perform administrative functions • Data review expertise across computerized systems including LIMS • Understanding of Audit trails, metadata, and system validation • Knowledge of Computer System Validation (CSV) and Computer System Assurance (CSA) • Data governance frameworks • Must be able to interpret raw data vs reported data discrepancies • Microsoft Office suite proficiency including Office Word, Excel, PowerPoint • Ability to organize tasks, work independently and adapt to changing priorities • Ability to function independently within a minimally supervised environment with exceptional attention to detail required • Demonstrated highly developed communication skills including well-developed writing skills and verbal and interpersonal skills • Must be able to read, write, speak, fluently and comprehend the English language • Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice.