Senior Quality Specialist
Job in
Princeton, Mercer County, New Jersey, 08543, USA
Listed on 2026-10-16
Listing for:
Kelly Science, Engineering, Technology & Telecom
Full Time
position Listed on 2026-10-16
Job specializations:
-
Quality Assurance - QA/QC
QA Specialist - Analyst/Manager, Regulatory Compliance Specialist
Job Description & How to Apply Below
Responsible for ensuring compliance with GLP requirements, applicable regulatory guidelines, and internal quality systems. The role independently conducts complex audits, supports regulatory inspections, leads quality investigations, and drives continuous improvement.
Key Responsibilities- Independently plan, conduct, document, and follow up on study, facility, process, system, and vendor audits. Support regulatory inspections and sponsor audits, ensuring ongoing inspection readiness.
- Lead or support investigations into deviations, non-compliances, and quality issues, including root-cause analysis and CAPA follow-up.
- Conduct risk assessments and provide quality guidance to support compliance and operational decisions.
- Own and develop an assigned QA focus area, such as Vendor Qualifications, Process Audits, or Continuous Improvement.
- Support the development, maintenance, and continuous improvement of the QMS.
- Improve audit methodologies, tools, and processes to enhance QA effectiveness.
- Degree in Science or related field
- 8 years of solid GLP experience, required
- Experience in GLP study audit, vendor audit and facility audit
- Experience working for CRO companies and bioanalytical laboratories
- Experience developing an audit schedule and annual audit plan
Position Requirements
10+ Years
work experience
To View & Apply for jobs on this site that accept applications from your location or country, tap the button below to make a Search.
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).
Search for further Jobs Here:
×