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Job Detail 
Job Detail

Job Summary
Principal Quality Auditor-Global Compliance
Job Code: 5356BR
POSTED: Nov 05
Salary: Open Location: Rochester, NY
Employer: Baush & Lomb Type: Full Time - Experienced
Category: Biomedical - Quality Required Education: 4 Year Degree



Employer Information
About Baush & Lomb

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 incl....more info

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Job Description
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.).

NOTES: Employer will assist with relocation costs

Requirements
Qualifications - 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.


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