Job Summary
- Company
- Bausch & Lomb
- Location
- Rochester, NY 14609
- Industries
- Biotechnology/Pharmaceuticals
- Job Type
- Full Time
- Employee
- Years of Experience
- 7+ to 10 Years
- Education Level
- Bachelor's Degree
- Career Level
- Experienced (Non-Manager)
Principal Quality Auditor-Global Compliance
About the Job
JOB DESCRIPTION
Experienced senior level auditor for the Global Quality Compliance audit. Will work to ensure Bausch & Lomb sites and functions maintain a compliant quality system by abiding by B&L policies and the laws/regulations of the countries in which our products are produced and marketed.
Job Duties:
- Responsible for leading and conducting global quality system audits (every 2 yrs. for sites, every 3 yrs. for distribution sites)
- Support audits of contract manufacturers and suppliers. This includes audit planning, execution, documentation and reporting with proactive follow up with Corrective Action Procedures(CAPA).
- Responsible for communication and documentation of internal and external compliance-related information. Includes changes in regulations, new guidelines and guidance documents from regulatory authorities and trade organizations.
- Responsible for continuous improvement initiatives.
- Inform senior management about compliance status in all areas of the business. Highlight delays, resource constraints that may adversely impact the business.
- Manage global quality projects including developing and/or obtaining necessary materials. Also, lead training for quality systems.
- Support external third party audits conducted in Rochester. Train and support global auditors and monitor their performance and compliance to requirements.
- Responsible for conducting special investigations that are highly sensitive in nature (data integrity investigations, due diligence assessment, etc.).
QUALIFICATIONS
-Must be willing to travel 40% (30% domestic & 10% foreign)
- Education: Bachelor’s Degree (Engineering, Chemistry, Biology, Microbiology or related technical field preferred).
- Experience: 8 years technical experience in a quality related function within a pharmaceutical and/or medical device environment.
- Certified auditor through education and experience preferred.
- Special Skills: Competency in ISO 13485: 2003/9001:2000, 21 CFR 820, 210 & 211 and Medical Device Directive desired.
- Knowledgeable in FDA requirements and experience with managing agency audits.
- Leadership skills, computer literate, strong written, oral communication, interpersonal skills ability to manage and prioritize multiple tasks and experience with computer programs (MS Word, Excel, PowerPoint).
- Specialized Training: ISO 9000 Lead assessor certification required or ability to be certified.
- ASQ Certification, CQA Certification, desirable.
- Previous experience in internal/external auditing required.
PLEASE APPLY ONLINE at the web address below and refer to requisition #5356
www.bausch.com/en_US/corporate/hr/general/careers_overview.aspx
Experienced senior level auditor for the Global Quality Compliance audit. Will work to ensure Bausch & Lomb sites and functions maintain a compliant quality system by abiding by B&L policies and the laws/regulations of the countries in which our products are produced and marketed.
Job Duties:
- Responsible for leading and conducting global quality system audits (every 2 yrs. for sites, every 3 yrs. for distribution sites)
- Support audits of contract manufacturers and suppliers. This includes audit planning, execution, documentation and reporting with proactive follow up with Corrective Action Procedures(CAPA).
- Responsible for communication and documentation of internal and external compliance-related information. Includes changes in regulations, new guidelines and guidance documents from regulatory authorities and trade organizations.
- Responsible for continuous improvement initiatives.
- Inform senior management about compliance status in all areas of the business. Highlight delays, resource constraints that may adversely impact the business.
- Manage global quality projects including developing and/or obtaining necessary materials. Also, lead training for quality systems.
- Support external third party audits conducted in Rochester. Train and support global auditors and monitor their performance and compliance to requirements.
- Responsible for conducting special investigations that are highly sensitive in nature (data integrity investigations, due diligence assessment, etc.).
QUALIFICATIONS
-Must be willing to travel 40% (30% domestic & 10% foreign)
- Education: Bachelor’s Degree (Engineering, Chemistry, Biology, Microbiology or related technical field preferred).
- Experience: 8 years technical experience in a quality related function within a pharmaceutical and/or medical device environment.
- Certified auditor through education and experience preferred.
- Special Skills: Competency in ISO 13485: 2003/9001:2000, 21 CFR 820, 210 & 211 and Medical Device Directive desired.
- Knowledgeable in FDA requirements and experience with managing agency audits.
- Leadership skills, computer literate, strong written, oral communication, interpersonal skills ability to manage and prioritize multiple tasks and experience with computer programs (MS Word, Excel, PowerPoint).
- Specialized Training: ISO 9000 Lead assessor certification required or ability to be certified.
- ASQ Certification, CQA Certification, desirable.
- Previous experience in internal/external auditing required.
PLEASE APPLY ONLINE at the web address below and refer to requisition #5356
www.bausch.com/en_US/corporate/hr/general/careers_overview.aspx
Bausch & Lomb is the eye health company dedicated to perfecting vision and enhancing life®.
We offer the world’s most comprehensive portfolio of eye health products, and we have one of the oldest, best known and most respected healthcare brands in the world.
The company began in 1853 in Rochester, New York, as a small optical shop that grew to become a multi-billion dollar corporation with approximately 13,000 employees worldwide, and with products available in more than 100 countries.
At Bausch & Lomb, our history of innovation continues today as we invent new materials, engineer new technologies, and create pioneering ways to help people see better.
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