• Temporary Quality Compliance Specialist

    System One (Alameda, CA)


    Job Title: Temporary Quality Compliance Specialist

     

    Type: Contract

     

    Compensation: up to $45/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.

     

    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

    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.

    #LI-EL1

    Ref: #568-Clinical

     

    System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

     

    System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.