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Sr. Quality Engineer

Charles River Laboratories International Inc (CRL)

Memphis, TN, US, 38118

Sr. Quality Engineer Req ID #:  213796 Location: 

Memphis, TN, US, 38118 Memphis, TN, US, 38118 For 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform. In return, we’ll help you build a career that you can feel passionate about.

 

IMPORTANT:   In order to be considered for this position, a resume/CV must be uploaded and submitted during the application process.  Please make sure work history and education are added correctly.   

  Job Summary This position reports to the Manager/ Senior Manager/ Assoc. Director of Quality Engineering and will be responsible for the conceptualizing, execution, evaluation, and monitoring of control of current and future processes in Quality and in Manufacturing relating to the Memphis Manufacturing Operations and associated Quality System Elements.   This position can lead and participate in internal and external audit programs, including client and regulatory audits, supplier analysis and approvals including responses and continuous improvements.  This position will act in a lead role and/or be an active participant on teams to perform process and system optimization for new clients, as well as to optimize commercial products, as requested.  This position will anticipate the need for and prepare risk assessments.  The position is a technical lead and subject matter expert to lead investigations, develop process improvements, and conceptualize/ execute statistical methods to analyze data.  

  Develop, and execute training and Management briefings on selected technical topics for Cell and Gene Therapy manufacturing and controls Lead Project Teams for any development or continuous improvement activities Lead or participate and execute any internal and external auditing functions, as needed. Review and approval of Systems, Facilities and Equipment Change Requests Issuing corrective action reports Conceptualize and install statistical sampling processes, improving and monitoring inspection processes Writing procedures, specifying inspection and testing equipment Job Qualifications Minimum BS/BA Life Sciences, quality engineering or related field. Minimum 8-11 years of experience in a biologics, pharmaceutical, medical device, or related industry, or an advanced degree applicable to the life sciences industry.  Previous experience in Cell and Gene Therapy is desirable, but not a require per say, if other experience in the regulated life sciences  Complete competency with electronic document managements systems and other information management systems Proficiency in Microsoft Office (Word, Excel, Outlook, etc.) is essential. Proficiency in Statistical tools and associated Apps (ex.: Smartsheet, Power BI, Minitab)

IMPORTANT: A resume is required to be considered for this position. If you have not uploaded your resume in your candidate profile, please return to upload field and attach your resume/CV. 

 

About Biologics Testing Solutions

With more than 50 years of experience and proven regulatory expertise, the Charles River Biologics group can address challenging projects for biotechnology and pharmaceutical companies worldwide. Offering a variety of services such as contamination and impurity testing, protein characterization, bioassays, viral clearance studies and stability and lot release programs, we support clients throughout the biologic development cycle, from the establishment and characterization of cell banks through preclinical and clinical studies to marketed products. Whether clients need stand-alone services, a unique package of testing, or insourced support, our Biologics group can create a custom solution to suit their needs.  Each year more than 20,000 biologic testing reports are sent each and over 200 licenses products are supported by our biologics testing solutions team.

 

About Charles River

Charles River is an early-stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development. Charles River also provides a suite of products and services to support our clients’ clinical laboratory testing needs and manufacturing activities. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their productivity and effectiveness to increase speed to market.

 

With over 20,000 employees within 110 facilities in 20 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client’s unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world. 

 

At Charles River, we are passionate about our role in improving the quality of people’s lives. Our mission, our excellent science and our strong sense of purpose guide us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe. We have proudly supported the development of 86% of the drugs approved by the FDA in 2021.

 

Equal Employment Opportunity

Charles River Laboratories is an Equal Opportunity Employer - all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, or national origin, veteran or disability status.

 

If you are interested in applying to Charles River Laboratories and need special assistance or an accommodation due to a disability to complete any forms or to otherwise participate in the resume submission process, please contact a member of our Human Resources team by sending an e-mail message to crrecruitment_US@crl.com. This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications.

For more information, please visit www.criver.com.

Nearest Major Market: Memphis

Job Segment: Pharmaceutical, Senior Quality Engineer, Medical Device Engineer, Quality Engineer, Manufacturing Engineer, Science, Engineering

Job posted: 2022-12-27

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