Sr. Quality Auditor, Greenville, SC at GREENVILLE

Job Description

Employee Value Proposition-EVP

This position offers growth and development opportunities within both the Quality and Operations groups since the job provides an avenue to learn all site processes and provides high visibility.

Position Summary

The Quality Auditor schedules, plans, performs, and documents periodic internal audits of the Greenville sites processes to determine the effectiveness and dependability of Greenvilles Quality Management System. The auditor monitors and is familiar with all quality regulations and standards for medical device and drug products, both US and international distribution points. The Quality Auditor supports external and supplier audits. The Quality Auditor supports the Quality Systems & Compliance department in other areas/projects as needed.

Specific Job Duties

• Develop and maintain annual internal audit schedule

• Develop internal audit plans

• Create and maintain electronic audit records in Catsweb Quality Management System (CQMS)

• Conduct opening/closing meetings

• Conduct internal audits

• Write internal audit reports

• Manage/ensure site is in compliance with internal audit timeframe/metrics

• Ensure site is auditing to current applicable standards/regulations

• Ensure internal auditor pool is qualified/trained

• Provide auditor development to other members of the auditor pool

• Observes safety rules and dress codes while conducting audits

• Support administration of external (3rd party) audits

• Support/conducts supplier audits, if needed

• Support other QSC tasks/projects as needed

Bausch + Lomb is one of the best-known and most respected healthcare brands in the world, offering the widest and finest range of eye health products including contact lenses and lens care products, pharmaceuticals, intraocular lenses and other eye surgery products. The company is solely 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.

Bausch + Lomb is an equal opportunity employer.

Job Requirements

• BS, preferably in a scientific discipline

• CQA or ISO Lead Auditor certification

• Minimum of 5 years of experience as a Quality Auditor in the medical device/pharmaceutical industry

• Demonstrate strong understanding of MDD, CFR, and ISO regulations and current industry practice with emphasis in pharmaceutical manufacturing

• Experience with ISO 9001 and 13485 required

• Experience in aseptic or sterile drug manufacturing preferred

• Strong organizational and communication skills required

• Demonstrated writing skills and proficiency with Microsoft Office

Managerial Responsibility

This position has no direct or indirect reports, but will facilitate and direct audit teams.

Country: USA, State: South Carolina, City: GREENVILLE, Company: Bausch + Lomb.