Senior QA Auditor

 

Charles River Laboratories, Preclinical Services is the world’s premier, full service, Preclinical Contract Research Organization. We provide scientific and technical expertise to the pharmaceutical and biotech industries, partnering with our clients in the development of compounds and bio-molecules from the early phases of discovery throughout development and into clinical trials.  This is a particularly exciting time to join the #1 preclinical CRO where you will work on a diverse range of innovative therapeutics within a fast-paced, buoyant business environment.

 

We currently have exciting opportunities for Sr QA Auditor in our new, state-of-the-art facility in Shrewsbury, MA, just 45 minutes west of Boston.

 

In this role a Senior (Sr.) Quality Assurance (QA) Auditor performs audits of protocols, in-life critical phases, raw data and final reports of medium to complex design to assure accuracy and compliance with the Good Laboratory Practice Regulations (GLP) and Standard Operating Procedures (SOP) and maintains written and signed records of auditing activities.
Sr. QA Auditor uses discretion and independent judgment in providing recommended corrective actions to management and the study director. 
Additional responsibilities include: perform site Quality System audits (process/facility/equipment/validation) and review of corresponding regulatory documentation to ensure compliance; perform qualification audit of subcontractors; assist with sponsor/agency site audits; assist QA management with collection and reporting of site quality metrics; and participate in QA projects.

 

 

Bachelor’s degree (B.S. /B.A.)  preferably in a life science, or equivalent. Certification/Licensure: RQA (GLP)

Minimum of 2 to 3 years in a Quality Assurance role.  Experience with Microsoft Office® applications and spreadsheet

programs such as Access and Excel.


Please forward your CV to Human Resources at  hr.shrewsbury@crl.com   for immediate consideration, and reference 'Sr QA Auditor LS MS’