Quality Systems Specialist I
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
Quality Systems Specialist I will report to the manager in the Quality Systems organization, which manages oversite of GMP systems such as deviations, CAPA, Change control, and OOSs. 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:
- Support and drive on time completion of investigations, CAPAs, Change controls, etc by closing out QMS documentation following GDP practices
- Participate in projects within the department as assigned by management
- Support Quality Systems processes and assist plant wide departments with quality systems process (e.g. Investigations, CAPA, Change Control, etc)
- Revise Standard Operating Procedures as assigned by management
- Develop and use quality and critical thinking skills
- Participate in continuous improvement projects
- Develop 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
- Perform other duties as assigned
Job Qualifications
- Bachelor’s Degree in life sciences or related field is required
- 0-2 years in GMP related experience in biopharmaceutical/pharmaceutical or related industry
- Experience with GMP regulatory requirements.
- Organized with paperwork
- 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
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Pharmaceutical, Laboratory, CAPA, Biology, Biotech, Science, Management