Temporary Quality Compliance Specialist
Listed on 2025-12-05
-
Healthcare
Data Scientist -
Quality Assurance - QA/QC
Job Title:
Temporary Quality Compliance Specialist
Location:
Alameda, CA
Type:
Contract
Compensation: up to $70/hr
Contractor Work Model: 100% Onsite
Joule is searching for a top-tier Quality Compliance Specialist to join our team for a high-impact, 6-month contract (with potential for extension). If you have a commanding background in Good Clinical Practice (GCP) and thrive on ensuring regulatory integrity, this is your chance to shine in a fast-paced environment.
- A strong academic foundation (Bachelor’s degree, preferably in Life Sciences or STEM).
- 5+ years of essential experience navigating the complexities of ICH GCP E6 R3 and other critical global regulations.
Take advantage of this exciting opportunity to advance your career while enjoying the beautiful San Francisco Bay Area backdrop!
Job Description:The Quality Compliance Specialist GCP/GVP QA is accountable for Good Clinical Practices (GCP) and Good Pharmacovigilance Practices (GVP) systems and activities, drives compliance and continuous improvement, ensures that Quality is integrated throughout GCP/GVP processes, supports and conducts audits as requested using a risk-based approach, implements Quality Risk Management (QRM), tracks and trends key metrics, and ensures clinical data integrity.
Education:- BS/B.Sc preferably in the life sciences or STEM disciplines and a minimum of 6 years of related experience
- Minimum of 6 years experience in biotech, pharmaceutical, or related industry or the equivalent combination of education/training and experience.
- This position requires knowledge and experience with GxP processes related to managing vendors, partners, and suppliers.
- Familiarity with FDA Quality System Regulations and Pharmaceutical guidelines, 21 CFR Part 210 & 211, US and EU regulations, ICH guidelines and other industry standards. ISO understanding is a bonus.
- Administrative experience in organizing and maintaining vendor and audit related records.
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