Qualification Coordinator
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.
Job Summary
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The Qualification Coordinator is a full time on-site position responsible for personnel qualifications in Cell Therapy Manufacturing Facility Located in Memphis, Tennessee. The Qualification Coordinator will be responsible for scheduling, executing, and maintaining qualifications for personnel at the Charles River Memphis Facility. Must be able to meet physical requirements in this job description.
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ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Lead daily tasks associated with performance of gowning qualifications, visual inspection qualifications, and operator qualifications
- Responsible for organization of scheduling and expiration dates to accommodate qualification of operators
- Maintain qualification records, track expiries, and related documentation in the Learning Management System (LMS)
- Work with cross functional teams (Quality Control Micro, Quality Assurance, Sterility Assurance) to facilitate testing and approvals
- Train personnel on aspects of qualification
- Provide guidance and mentoring for staff to further develop their skills
- Draft Quality Management System (QMS) documents such as Job Aids, Procedures, Deviations, and Corrective and Preventative Actions (CAPA)
- Maintain qualification details in site QMS/LMS database
- Perform all other related duties as assigned.
Job Qualifications
- Bachelor’s degree in a Life Science, Education, or related field preferred.
- Minimum of 3-years of GMP, scheduling, or teaching experience preferred.
- Ability to multi-task effectively.
- Excellent written and verbal communication skills.
- Experience with document management/LMS systems
- Able to communicate effectively with various ages, learning styles, and personalities.
- Must be detail-oriented and have excellent organizational skills.
- Demonstrated ability to work with others in a multicultural environment
- Prior experience in a cGMP facility and CFR21.211
- Prior experience with qualification and visual inspection preferred
The pay range for this position is $64,600 - $72,200. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.
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 over 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 [email protected]. 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, Quality Assurance, CAPA, Database, Science, Technology, Management