Sr Preclinical Quality Auditor

Boston Scientific•Arden Hills, MN

12d•$85,000 - $161,500•Remote

About The Position

Assists with internal quality assurance program for preclinical GLP studies. Conducts internal and external GLP quality audits to assure that BSC preclinical trials comply with all applicable regulatory requirements, standards and BSC policies and procedures. Supports Inspection Readiness and Preclinical Corrective and Preventative Action (CAPA).

Requirements

Associate’s degree
5 or more years of preclinical experience
Demonstrated experience working within a Good Laboratory Practice (GLP) regulated environment, including knowledge of and application of 21 CFR Part 58 regulations governing nonclinical laboratory studies.
Ability to communicate with all levels of the organization
Travel up to 30% (domestic and international).

Nice To Haves

Bachelor’s degree
3 or more years of direct preclinical quality (GLP) auditing experience
RQAP-GLP certification
ISO17025 audit certification
ASQ Quality Auditor certification

Responsibilities

Supports the preclinical study teams as the Preclinical Quality consultant.
Conducts audits for assigned preclinical GLP studies and follows audits to closure.
Documents audit observations; evaluates impact and responses to audit findings and ensures the appropriate corrective actions are completed.
Provides support to GLP test site for audits by a Regulatory Authority/Competent Authority, as applicable.
Provides support during a Regulatory Authority/ Competent Authority inspection of Boston Scientific preclinical processes and GLP studies.
Supports the integration of preclinical processes of business acquisition and acquired preclinical GLP studies, as assigned.
Supports internal process improvements, as assigned.
Supports the CAPA process, working cooperatively with preclinical NCEP/CAPA owners.
Supports preclinical teams in gathering and reporting various performance metrics
Plans, schedules, and conducts preclinical vendor audits.