Quality Systems Specialist 2

Req ID #:  179991
Location: 

Memphis, TN, US, 38118 Memphis, TN, US, 38118

For 70 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 II 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:

  • Manage the on-time completion of CAPAs, Change Controls, Deviations, etc
  • Prepare and communicate Quality Systems performance metric
  • Drive continuous improvement in quality systems process to reduce waste
  • Author and revise SOPs and FORMs
  • Lead by example in regards to GMP, GDP, and Quality
  • Lead continuous improvement projects in the quality organization
  • Lead cross functional meetings to drive efficiency in quality document completion
  • Revise Standard Operating Procedures as assigned by management
  • 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

EDUCATION AND/OR WORK EXPERIENCE REQUIREMENTS

  • Bachelor’s Degree in life sciences or related field is preferred
  • 2-4 years in GMP related experience in biopharmaceutical/pharmaceutical or related industry OR 4 years of combined education and work experience is required
  • Experience with GMP regulatory requirements.
  • Ability to prioritize daily activities to meet client needs on time of established timelines in a fast- paced 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. 


Vaccine Mandate
Charles River is a U.S. Federal Contractor.  As a result, we must follow the Presidential Executive Order to mandate vaccinations, and ensure our employees are fully vaccinated against COVID-19.  Our main priority is the wellbeing, health, and safety of our people. We require proof of vaccination from all employees. 


Anyone with requests for disability-related and/or religious exemptions should contact Talent Acquisition (crrecruitment_US@crl.com) so that information can be provided about the accommodation process at Charles River.

 

About Cognate BioServices
Cognate BioServices, Inc., a Charles River Company, is the premier commercial-ready CDMO for cell and gene therapy needs. We are a dynamic, results-driven organization focused on providing the broadest range of expertise across the various cell types and technologies used in the commercialization of cell & gene therapies for regenerative medicine, cellular immunotherapy, and advanced cell therapy companies, organizations, and institutions.


We offer a unique combination of standard and custom services to companies across all points of clinical and commercial development. Our development and manufacturing services are focused on clients seeking rapid development of products from clinical studies into commercial manufacturing, with a unique capacity to handle all aspects of scale-up and commercial readiness.


Cognate leverages the combined know-how and expertise of its business, scientific, and technical teams to successfully develop and manufacture autologous and allogenic products across multiple cell-based technology platforms from start to finish, for you and your patients.


For more information, visit www.cognatebioservices.com 


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, 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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