Quality Systems Specialist III

Quality Systems Specialist III Req ID #:  214728 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  

Sr Quality Systems Specialist will report to the manger in the Quality Systems organization, which manages oversite of GMP systems such as deviations, CAPA, Change control, OOSs, and document control.  You will support the site’s execution of and compliance to GMP, GDP, and FDA requirements by maintaining QMS data and overseeing the quality of regulatory documentation

The essential duties/responsibilities include: Train QA Specialist I and II team members on pertinent use of QMS (Investigations, CAPA, Change Control, etc) Audit and support performance of investigations, CAPAs, Change controls, etc Lead projects within the department as assigned by management Provide coaching on quality systems utilized in the site Support Quality Systems processes and assist plant wide departments with quality systems process (e.g. Investigations, CAPA, Change Control, etc) Prepare and communicate Quality Systems performance metric Revise Standard Operating Procedures as assigned by management Lead continuous improvement projects in the quality organization Have understanding of manufacturing processes and quality systems elements Communicate with other managers for process improvements and quality concept Have excellent written and verbal communication skills Job Qualifications Bachelor’s Degree in life sciences or related field preferred, not required Minimum of 4 years in GMP related experience in biopharmaceutical/pharmaceutical or related industry OR 4-6 years of combined education/related work experience in biopharmaceutical/pharma or related industry Experience with GMP regulatory requirements. Ability to prioritize daily activities to meet client needs on time of established timelines in a fast- paced environment. Have leadership skills in a quality environment Detailed oriented

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, Laboratory, CAPA, Document Control, Biotech, Science, Management, Administrative