Quality Assurance Specialist III

Qualifications: Minimum Required: 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) Other Required: 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 . For CA applicants, please also refer to our CA Privacy Notice . Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at myHR@precisionmedicinegrp.com . Recruitment Fraud Warning: Please be aware that fraudulent individuals and websites may impersonate Precision Medicine Group or its affiliates and attempt to obtain personal, financial, or banking information through fake job postings or employment offers. Precision Medicine Group will never request payment, banking details, or other sensitive financial information as part of the recruitment process. If you believe you have been targeted by a recruitment scam, we encourage you to report the incident to your local law enforcement authorities, consumer protection agency, or relevant cybercrime reporting organization in your country. Please also notify us at myHR@precisionmedicinegrp.com so we can investigate and take appropriate action.