Analytical & Microbiology QA Lab Manager (3069)

Employer
Avanos Medical, Inc.
Location
Casas Adobes, Arizona, US
Salary
Competitive
Posted
Jul 12, 2021
Closes
Jul 28, 2021
Ref
2312801868
Discipline
Biology
Employment Type
Full time
Salary Type
Salary
Requisition ID: 3069 Job Title: Analytical & Microbiology QA Lab Manager Job Country: United States (US) Here at Avanos Medical, we passionately believe in three things: * Making a difference in our products, services and offers, never ceasing to fight for groundbreaking solutions in everything we do; * Making a difference in how we work and collaborate, constantly nurturing our nimble culture of innovation; * Having an impact on the healthcare challenges we all face, and the lives of people and communities around the world. At Avanos you will find an environment that strives to be independent and different, one that supports and inspires you to excel and to help change what medical devices can deliver, now and in the future. Avanos is a medical device company focused on delivering clinically superior breakthrough solutions that will help patients get back to the things that matter. We are committed to creating the next generation of innovative healthcare solutions which will address our most important healthcare needs, such as reducing the use of opioids while helping patients move from surgery to recovery. Headquartered in Alpharetta, Georgia, we develop, manufacture and market recognized brands in more than 90 countries. Avanos Medical is traded on the New York Stock Exchange under the ticker symbol AVNS. For more information, visit www.avanos.com. The role The incumbent provides technical leadership, consultation, and leading validations regarding laboratory testing, laboratory and technical process equipment, manufacturing environmental control, and other scientific or technical equipment or processes. Additionally, this position provides technical consultation to Regulatory affairs, R&D, Marketing, Quality Assurance and Procurement. The incumbent is responsible to provide technical work direction to the Tucson Analytical and Microbiology Laboratories Quality Team. This team provides chemistry and/or microbiology testing services for raw materials, products, environmental monitoring samples, sterility assurance compliance samples, and PYtest breath test patient samples. This team is also responsible for the production of PYtest Drug Substance, breath test diagnostics, and for providing technical support for CLOtest, Silver Coated Catheters, and Oral care product lines. Essential Duties and Responsibilities: * The incumbent provides technical leadership, consultation, and leading validations regarding laboratory testing, laboratory and technical process equipment, manufacturing environmental control and other scientific or equipment or processes. Additionally, this position provides technical consultation to Regulatory affairs, R&D, Marketing, Quality Assurance, and Procurement. * Determine laboratory requirements necessary to support the laboratory strategy - e.g. identify equipment, environmental controls, space, etc. Establish laboratory procedures according to regulations and standards. * Provide technical work direction to the Tucson Analytical and Microbiology Laboratories Team regarding the systems for chemistry and microbiological testing, environmental monitoring of clean room and controlled manufacturing areas, product stability testing, product bioburden testing, and drug retains, Certificates of Analysis, and Certificates of Manufacture. * Ensure maintenance of laboratory equipment and adequate laboratory supplies to ensure ongoing lab operations. * Ensure team objectives for Safety, Quality, and Productivity are established. Ensure team members are properly trained and required documentation is complete and accurate. * Provide technical work direction for the Diagnostics Manufacturing of PYtest Drug Substance and provide technical support for the PYtest, Silver Coated Catheters, Oral Care, and CLOtest product lines. Ensure that sufficient and high-quality products are manufactured to prevent back orders within the structure of regulatory compliance. * Promote improvement in manufacturing processes and assist R&D, as necessary, in the implementation of new products and processes. * Maintain compliance with FDA, NRC, ARRA and ISO regulations and standards within areas of responsibility. * Provide Leadership for the PYtest breath test patient sample testing process to promote the quick, efficient, and accurate transfer of data for the best possible impact on patient outcomes. * Maintain an active role with the Internal Audit Team and perform other audits as necessary. Your qualifications Required: * The qualifications for this position require a combination of education, experience and training appropriate for the scope of the position * Minimum requirement of bachelor's degree in a relevant scientific discipline and ten to twelve years of experience, or combinations of advanced degrees and lesser amounts of relevant experience. * Evidence of a solid background of specialized knowledge and leadership experience is desired. Preferred: * Experience dealing with patient sample testing (clinical samples). Avanos Medical is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, sexual orientation, gender identity or any other characteristic protected by law. If you are a current employee of Avanos, please apply here . Join us at Avanos Join us and you can make a difference in our products, solutions and our culture. Most of all, you can make a difference in the lives, people, and communities around the world. Make your career count Our commitment to improving the health and wellbeing of others begins with our employees - through a comprehensive and competitive range of benefits. We provide more than just a salary - our Total Rewards package encompasses everything you receive as an employee; your pay, health care benefits, retirement plans and work/life benefits. Avanos offers a generous 401(k) employer match of 100% of each pretax dollar you contribute on the first 4% and 50% of the next 2% of pay contributed with immediate vesting. benefits on day 1

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