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Principal Quality Auditor-Global Compliance Job
Date: Oct 31, 2009
Location: Rochester, NY, 14673, USA
Job Title:
Principal Quality Auditor-Global Compliance
Req #:
5356BR
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
-
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.
Work Location NY - Rochester-1400 N Goodman Street Relocation Available Yes Status Full-Time
Principal Quality Auditor-Global Compliance
Req #:
5356BR
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
-
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.
Work Location NY - Rochester-1400 N Goodman Street Relocation Available Yes Status Full-Time
Nearest Major Market: Rochester
Job Segments: Accounting, Compliance, Finance, Legal
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