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Principal Quality Auditor 3343 Rochester, NY Perm/Full $65,000 - $75,000

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Principal Quality Auditor
Responsible for leading and conducting global quality system audits to assure that all sites and departments within the Company implement and maintain an appropriate quality system and adhere to the Company policies and the laws and regulations of the countries in which products are produced and marketed.

Responsible for leading and conducting audits of contract manufacturers and suppliers, relative to corresponding quality systems and regulatory standards and requirements. This includes audit planning, execution, documentation and reporting with proactive follow-up with CAPA.

Responsible for the development and maintenance, as a recognized technical resource, of quality systems that adhere to the Company compliance policies and procedures and the laws and regulations of the countries in which products are produced and/or exported.

Responsible for the communication and documentation of internal and external compliance-related information, including changes in regulations, new guidelines and guidance documents, and other information from regulatory authorities and trade organizations, to all the Company sites.

Responsible for continuous improvement initiatives to ensure that the Company continues to meet expectations in an evolving regulatory environment, while striving to meet business excellence goals.

Inform senior management, on an ongoing basis, about the compliance status in all areas of the business, and highlight any delays and resource constraints that could adversely impact the business.

Manage global quality projects as directed by supervisor, including developing and/or obtaining necessary materials and leading training in the area of quality system requirements as defined by the Company Policies and Procedures and the regulations.

Support external third party audits conducted in Rochester. Train and support global auditors and monitor their performance and compliance to global requirements.

Responsible for conducting special investigations that are highly sensitive in nature (data integrity investigations, due diligence assessment, etc.).
Qualifications Education: Bachelor’s Degree in Chemistry, Biology, Microbiology, or related field. Advanced degree is a plus.

Experience: 8+ years of technical experience in a quality engineering-related function in a pharmaceutical and/or medical device environment, responsible for developing and implementing quality systems that includes either five years of Pharmaceutical GMPs and/or a knowledge of Device QSRs and ISO 13485.

Special Skills: Lead assessor certification or ASQ CQA certification is a must. Leadership skills, strong written, oral communication and interpersonal skills. Demonstrated hands-on ability to lead cross-functional audit teams.

Specialized Training: ISO, GMPs, GLPs, MDD, GCPs desired. Knowledgeable of FDA requirements and experience with managing agency audits. Must be certified or certifiable as an auditor through education or experience.