Temporary Quality Compliance Specialist
Alameda, CA
Experience: 0
Category: Scientific & Clinical
Contractor Work Model: Onsite
Brand: Joulé
Job ID: 343304
Date Posted: 12/02/2025
Shortcut: http://jobs.systemone.com/az2XIu
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.
We need a sharp mind with:
- 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.
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.
Ref: #568-Clinical
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