Sr Preclinical Quality Auditor

Sr Preclinical Quality Auditor

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).

Your responsibilities include:

• 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.

What we're looking for in you:

Minimum 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).

Preferred Qualifications:

• Bachelor's degree
• 3 or more years of direct preclinical quality (GLP) auditing experience

• The following certifications are desirable:

• RQAP-GLP
• ISO
  17025 audit certification
• ASQ Quality Auditor

Compensation for non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation for exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.