Senior Quality Auditor

Date: Sep 15, 2022

Location: US-NY-Rochester, New York, US

Company: Bausch & Lomb

Bausch + Lomb (NYSE/TSX: BLCO) is a leading global eye health company dedicated to protecting and enhancing the gift of sight for millions of people around the world—from the moment of birth through every phase of life. Our mission is simple, yet powerful: helping you see better, to live better.

Our comprehensive portfolio of over 400 products is fully integrated and built to serve our customers across the full spectrum of their eye health needs throughout their lives. Our iconic brand is built on the deep trust and loyalty of our customers established over our nearly 170-year history. We have a significant global research, development, manufacturing and commercial footprint of approximately 12,500 employees  and a presence in approximately 100 countries , extending our reach to billions of potential customers across the globe. We have long been associated with many of the most significant advances in eye health, and we believe we are well positioned to continue leading the advancement of eye health in the future. 

 

 

Position summary:

The Senior Quality Auditor is responsible for assessing the level of compliance of Bausch+Lomb’s External Manufacturers with applicable cGMP and regulatory standards (e.g. 21 CFR parts 11, 58, 201-211, 820, 111, ISO 13485, ISO 9001, ISO 17025, ICH Q7) as well as B+L’s quality standards.

 

Key responsibilities:

 

  • Schedule, plan, execute, report, follow-up and close supplier audits (GMP, GLP, GCP)
  • Support preparation of annual Regional Supplier Audit Schedule
  • Prepare and report supplier audit metrics
  • Monitor and track supplier audit corrective action plans
  • Member of the Technical Auditing Committee and sub-teams
  • Develop and enhance Supplier Quality Audit Systems  to reduce risk and increase compliance
  • Conduct Regional Compliance audits
  • Participate in Good Clinical Practice audits
  • Conduct For Cause Audits
  • Monitor FDA audits and other regulatory actions regarding suppliers

 

Qualifications/experience:

  • BS Degree in a scientific/technical discipline (Chemistry, Microbiology, Engineering)
  • Certified Quality Auditor (ASQ or other)
  • Minimum of 5 years of experience in FDA regulated industries (pharmaceuticals and medical device) with 5 years in a cGMP audit role. Prefer a person which has both pharmaceutical and device experience.
  • Working knowledge of 21 CFR 11, 210, 211, 820, 111, ICH, ISO 13485
  • Extensive training in Quality Assurance concepts and applications including Internal Auditing, Supplier Auditing, Quality Engineering, Sterility Assurance, Statistics.

  

 

This position may be available in the following location(s): US - Rochester, NY (GEHC)

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

Job Applicants should be aware of job offer scams perpetrated through the use of the Internet and social media platforms.

To learn more please read Bausch+Lomb's Job Offer Fraud Statement.