Temporary Quality Compliance Specialist
Joulé
Alameda, CA
JOB DETAILS
SALARY
LOCATION
Alameda, CA
POSTED
4 days ago
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.
About the Company
J
Joulé
With extensive scientific, clinical, and healthcare industry experience, Joulé recruiters excel at placing talent across core specialty areas:
- Scientific staffing for hard-to-find skills
Working across every scientific discipline, Joulé places biologists, chemists, scientists, technicians and other specialists.
- Clinical lifecycle recruiting
From research to regulations, safety to statistics, Joulé helps clients manage every stage of the clinical development lifecycle.
- Equipment calibration, maintenance and validation
Laboratory and facility support comes with a total quality commitment backed by ISO 9001:2008 certification.
- National healthcare recruitment
Trust Joulé’s extensive experience in physician, advanced practice provider and executive direct placement search.
COMPANY SIZE
500 to 999 employeesINDUSTRY
Biotechnology/Pharmaceuticals
WEBSITE
https://www.jouleinc.com/