Reynolds American Inc. (RAI) QA Specialist IV KBP in Owensboro, Kentucky
QA Specialist IV KBP
Date:Mar 9, 2018
Location:Owensboro, KY, US
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 RAI, 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.
At the RAI companies you’ll have the opportunity to work on iconic brands and revolutionary products by collaborating with visionary, principled and passionate people every day.
This position is within Kentucky BioProcessing (KBP)—a world leader in using the tobacco plant as a biopharming platform to produce proteins and pharmaceuticals with expertise in extraction and purification.
This position will lead in the development, maintenance and improvement of the Quality Management System (QMS) and serve within the on-site Quality Assurance function. The QA Specialist IV role will have responsibility for quality assurance requirements required by the products, processes, and facilities at the site. Activities require communication with internal and external customers, operations management, vendors and consultants.
Principal Duties and Responsibilities:
Ensure consistency in document management through document review, updates and improvements to process flows and SOPs/SLPs/Work Instructions, and provide technical writing support, consulting, investigation, identification and edits, with oversight from QA management
Support regulatory inspections and ensure adequacy of the quality system
Plan and lead audits for adherence to FDA, GMP, and Risk management (i.e. HACCP) plans; provide final reports with audit findings and follow-up support
Plan and conduct routine studies and tests, as appropriate, assist with implementation of project plans, collects and reports data and trending. Apply standard quality, auditing, sampling and testing, or other theories, concepts and techniques
Lead/support site specific QA processes related to Document control, CAPA/Deviations, Non-Conformance, Planned Deviation, and Change Control
Review and/or approve documentation generated at the facility while performing procedures required by the quality system, these may include, but not limited to:
Product Stability and Laboratory Records
Equipment Calibration, Maintenance, and Cleaning Activities
Facilities, HVAC, Water Systems monitoring
Perform technical quality work with limited direction from management, that may include periodic review of records (Master Production Records, Batch Release, COA generation, calibration, retention samples, etc.), and serve as the point of contact for various initiatives such as validation/qualification for equipment, facilities and processes as applicable
Perform managerial, administrative, and subject matter expert roles during regulatory inspections
Support of GMP production and engineering areas as appropriate with labeling and inventory
BS degree in Science or Quality with relevant experience; OR
Associate degree with relevant experience (3+ yrs); OR
High School diploma or equivalent with relevant experience (5+ yrs)
General knowledge of QMS, GxP, ISO and Pharmaceutical Manufacturing processes (ISO9001, ISO13485, 21 CFR 210, 21 CFR 211, 21 CFR 820)
Previous experience working in a quality capacity at a GMP Pharmaceutical manufacturing facility
Experience in troubleshooting, root cause analysis, and deviation resolution
Experience with QA metrics development and trending
Experience with CAPA systems
Experience working with Microsoft Office Professional Suite
Strong Quality background with knowledge of GMP QMS in a Pharmaceutical facility
Strong technical skills with high attention to detail
Ability to apply standard quality theories, concepts and techniques
Ability to work independently and make decisions with minimal oversight
Results oriented with the ability to prioritize and multi-task to meet workload expectations and/or project and contract deadlines
Knowledge of Audit Process, reporting systems, and databases
Ability to communicate effectively in oral and written form
Willingness to acquire and maintain appropriate quality certifications for role (CQE, CQA, Six Sigma, HACCP auditor, etc).
Experience with quality aspects of HVAC/Clean Rooms
Ability to review system drawings, plans, Qualification, Verification, and Validation experience
Competitive Annual Salary
Targeted Annual Bonus
Relocation assistance available for those who qualify.
Our company offers very competitive compensation and benefit plans, including:
401(k) plan that offers opportunity to save on pre- and post-tax basis up to 50 percent of eligible compensation. Company matches 100 percent of employee pre-tax/Roth (401k) contributions up to six percent
Comprehensive health- and welfare-benefits package
Eleven paid company holidays annually, plus a generous paid vacation plan based on length of service
Company-paid sick and personal days, funeral leave and jury duty leave
Confidential personal financial counseling service
On-site health clinics and fitness centers
A matching grants program that enables employees to direct and double their donations to qualifying charitable organizations of their choice
Health-care advocacy service
Volunteer service opportunities
Federal credit union membership through Allegacy Federal Credit Union
Extensive training opportunities
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; Niconovum USA, Inc.; Niconovum AB; R. J. Reynolds Vapor Company; Lorillard Licensing Company, LLC; and Reynolds Brands, Inc..
Reynolds American Inc. and its affiliated companies is an Equal Opportunity / Affirmative Action Employer.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
Our organization offers a level of challenge, responsibility and creativity for motivated employees that stands apart from the crowd.
We are also committed to employing a diverse workforce and valuing different perspectives, experiences and talents to maximize the company's potential for successfully achieving its business objectives.
Onlyapplicants requiring reasonable accommodation for any part of the application and hiring process should contact us directly.
Nearest Major Market:Owensboro