Quality Assurance Specialist III

About the Role

The QA Specialist provides independent Quality support for GLP and GCLP studies by performing document review, protocol and experiment record review, data review, and quality event oversight activities.

The role focuses on ensuring data integrity, traceability, and compliance with internal SOPs and applicable regulatory expectations, while maintaining strict independence from study execution. This position includes high‑value QA activities that can be performed remotely, with controlled system access and clear separation from operational responsibilities.

, access, security, validation) -Data lifecycle controls (collection, processing, reporting) -Assess compliance with: -ALCOA+ principles -21 CFR Part 11 / Annex 11 for electronic systems -Identify: -Data discrepancies, manipulation risks, or gaps -System vulnerabilities affecting data reliability Miscellaneous: -Assist in training new and existing personnel, as needed -Participate in regulatory, notified body, and customer audits as needed -Provide back-up coverage for other Quality Specialists -Carry out other duties/projects as assigned

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 Privacy Policy.
• For CA applicants, please also refer to our CA

Additional Information

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. com .

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