Share Email Opening Title Quality Engineer  About the Organization kaléo is a new type of pharmaceutical company, dedicated to building innovative solutions for serious and life-threatening medical conditions.   Description PURPOSE, OBJECTIVES, FUNCTIONS: The Quality Engineer I (QEI) is responsible for providing quality oversight to contract suppliers to ensure products or services are produced to meet GMP requirements. The Quality Engineer is responsible for monitoring Contract Suppliers KPIs and to assure that Contract Supplier’s quality systems are effective and proactively implemented to facilitate seamless production of products. This position is responsible for working with the Director, Quality Operations to ensure the quality systems meet the quality standards and requiremenst of kaleo policies, FDA regulations and European Union guidance documents. Essential Functions: Work closely with Supply Chain Management, Product Development, and Regulatory Affairs to facilitate supplier manufacturing process transfer for pharmaceutical, device and combination products Day-to-day Contract Supplier management and quality oversight Batch record review and release Supplier production metrics analysis Initiate, review or participate in kaléo Change controls, NCRs, complaints, deviations Provide oversight to supplier’s investigations review and approval Participate in Contract Suppliers Corrective Action activities to the degree necessary to assure effective solutions are inplace Work with suppliers to ensure their APR reports are submitted to kaléo on time. 25-50% travel to Contract Supplier locations Additional Responsibilities: Participation in the development and review of documentation Assist in defining/developing Quality System performance measurements and reporting requirements AUTHORITIES: Provide quality oversight to CMO’s during product production Identify and investigate nonconformance, deviations, corrective and preventative actions at CMO’s   Open Date 10/29/2017   Position Requirements EMPLOYMENT REQUIREMENTS: BS Degree in a Life Science or Engineering 1-3 years of related experience in medical devices preferred; biopharmaceuticals or parenteral manufacturing required POSITION QUALIFICATIONS: Experience working with CMO’s at the production level Working knowledge of basic quality systems regulations such as FDA, CFR and ISO Working knowledge of fundamental quality and statistical tools   Exempt/Non-Exempt Exempt   Full-Time/Part-Time Full-Time   EOE Statement We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, national origin, disability status, protected veteran status or any other characteristic protected by law.   Location Corporate   This position is currently not accepting applications. To search for an open position, please go to http://KaleoPharma.appone.com WE ALSO RECOMMEND Other Jobs Within Same Category -- None found -- Other Jobs Within 60 Miles -- None found -- Follow us See who works here:

 

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