The Lead Manager QA Supplier Auditor has the responsibility to conduct audits of suppliers and internal processes as identified by Quality Assurance and based on the applicable regulatory requirements of the assigned site. This position is also responsible for supporting the supplier management process ensuring that supplier performance and qualification activities are reviewed and appropriate improvement tasks are undertaken. The Lead Manager QA Supplier Auditor provides leadership and serves as a mentor to the audit team.
Principal Duties and Responsibilities:
Plan and lead audits for adherence to defined supplier requirements, FDA, GMP, and Risk management (i.e. HACCP, FMEA) plans; provide final reports with audit findings and perform corrective action follow-up
Ensure suppliers and contract manufacturers meet the commitment to support successful material performance through frequent communication and periodic supplier audits
Support supplier management activities including performance monitoring, qualification, contingency planning, Corporate Social Responsibility efforts and continuous improvement by participating on commodity-specific teams
Implement project plans, the collection and reporting of data, and trend analysis
Apply standard quality, auditing, or other theories, concepts and techniques
Act as the point of contact for metrics, reporting and data analysis integrity
Provide information for the investigation and resolution of supplier complaints
Collaborate with Quality Control personnel and suppliers to troubleshoot material complaints and develop timely resolutions
Lead teams to develop and plan strategies, as appropriate, for enhancing raw material quality
Schedule, organize, and facilitate meetings as necessary
Ensure consistent application of Company policies. Serve as a role model of the Company's Core Values
Demonstrate credibility and expertise as related to Quality Assurance procedures
Perform the role of Records Coordinator for the Supplier Quality Assurance department, as applicable.
Minimum of three (3) years of experience auditing GXP Quality Systems in a Quality Assurance/Quality Control role in a regulated environment
Minimum of two (2) years of experience in auditing external suppliers/vendors
Solid knowledge of QMS, GXP, ISO and Manufacturing processes applicable to the assigned site (i.e., ISO9001, ISO13485, 21 CFR 210, 21 CFR 211, 21 CFR 820
Must possess the knowledge and ability to effectively conduct different types of audits as appropriate for the method, relationship, or purpose of the audit
Must possess audit certification from a recognized association
Must be able to audit in a professional, ethical, and objective manner using and interpreting applicable standards or company requirements
Must be able to effectively plan, communicate, and execute an audit within the defined scope, schedule resources, conduct necessary meetings, and use appropriate techniques to gather, identify, and classify objective evidence
Must be able to verify, document and communicate audit results, develop an audit report, and evaluate the effectiveness of corrective action and follow up
Knowledge of applicable FDA and ISO standards and requirements applicable to facility being audited
Strong quality background (sampling, testing, calibration, metrology, qualification, validation, principles and practical application) or technical background with capacity to gain Quality background
Experience with manufacturing processes in a regulated industry
Strong problem-solving, risk analysis and analytical skills
Ability to work independently and make decisions with minimal oversight
Effectively work in a team environment
Expertise with Microsoft Office, quality systems, & computer applications
Very knowledgeable of material and machine interaction
Results oriented with the ability to prioritize and multi-task.
Strong knowledge of Tobacco, Pharmaceutical, or Medical Device regulatory compliance inclusive of FDA/ISO regulations as required for GMP compliance
Knowledge of Tobacco manufacturing processes
Excellent leadership, communication, and organizational skills
Demonstrated knowledge of Lean and Continuous Improvement principles
Ability to travel (foreign and domestic) - approximately 30%
Regular attendance at work
Internal Number: 29345
About Reynolds American
Reynolds American Incorporated is positively transforming the tobacco industry. We’re a family of companies that strives for success in everything we do. The future inspires us because our people are igniting the breakthroughs that are redefining the ways adult tobacco consumers enjoy tobacco in the 21st century.
When other companies talk about growth, they only talk about size. At Reynolds American, we focus on the growth of our people. We take pride in each other’s growth and well-being throughout our careers. We invest in your career and total well-being because we know our companies succeed when our people thrive.
ABOUT OUR ORGANIZATION:
Reynolds American Inc. is an indirect, wholly owned subsidiary of British American Tobacco p.l.c., and the U.S. parent company of R. J. Reynolds Tobacco Company; Santa Fe Natural Tobacco Company, Inc.; American Snuff Company, LLC; Modoral Brands, Inc.; R. J. Reynolds Vapor Company; Lorillard Licensing Company, LLC; Reynolds Brands, Inc.; and Vuse Stores LLC. This position is with RAI Services Company (2200).
Here, you’ll have the opportunity to work on iconic brands and revolutionary products by collaborating with visionary, principled and passionate people every day.