QC Analyst I, Raw Materials

QC Analyst I, Raw Materials Req ID #:  143016 Location: 

Memphis, TN, US, 38104 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  

We are seeking a QC Analyst I, Raw Materials for our Cognate BioServices site located in Memphis, TN.  

Cognate is seeking applicants for the QC Raw Material Analyst I position. As a key member of our Quality Control department, the Analyst is responsible for the day to day activities covering the inspection, sampling and testing of incoming raw materials. The analyst will report into the Manager and/or Supervisor of the QC Raw Material Department.

ESSENTIAL DUTIES AND RESPONSIBILITIES

•Responsible for the inspection, sampling and testing of incoming raw materials per Standard Operating Procedures.

•Accurately follow established procedures and perform tasks in accordance with testing schedule and cGMP requirements.

•Record, compile, review and report data per cGMP.

•Ensure data storage and archiving are performed per established procedures.

•Ensure that instruments and equipment used in inspection and sampling are kept in a qualified and calibrated state.

•Ensuring all at-risk product is under control, properly dispositioned and exposure to further deficiencies mitigated.

•Report discrepancies and nonconforming materials to management and support investigation.

•Assist in investigations; such as CAPAs, 5 Why’s and Root Cause Analyses.

•Provides technical assistance in the laboratory regarding raw materials. Ensuring they are tested, documentation reviewed and filed, and making determination of their status.

•Maintain the sampling and retention rooms are at constant state of compliance and inspection readiness at all times.

•Maintain sampling and retention rooms’ inventory of cleaning solutions, sample containers, labels, etc Job Qualifications The following are minimum qualifications related to the QC Analyst I, Raw Materials position:

• A.A. or B.S. degree in Chemistry, Biochemistry, Biology or related discipline is required.

• A minimum of 0-2 years of experience in a commercial QC incoming inspection, sampling and testing environment, preferably with raw materials and/or devices, visual inspection and inspection by attributes.

• Experience with wet chemistry techniques.

• Familiar with laboratory equipment; such as HPLC, GC, OSMO, pH meter and/or NIR

• Strong working knowledge of cGMP, GDP, and GLP.

• Experience with laboratory information management systems (LIMS)

• Highly collaborative with the proven ability to work in a cross-functional team.

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 by December 8, 2021.  Our main priority is the wellbeing, health, and safety of our people. We will be requiring 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 - M/F/Disabled/Vet.

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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