Quality Control - Analyst Raw Materials

Quality Control - Analyst Raw Materials Req ID #:  199373 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 Charles River Biologics in Memphis 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.

•Make determination of status regarding a raw material with available information from COA and interpretation of test results.

•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 deficiency is mitigated.

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

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

•Maintain close interaction and communication with the Materials Management team and QA to ensure on-time and aligned raw-material-related decisions.

•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 EDUCATION AND/OR WORK EXPERIENCE REQUIREMENTS

• 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

• Experience with Supply Chain logistics and material release processes is desirable.

• Familiarity with EU Regulations is a major plus, but not required.

• 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.

• Strong attention to detail, very organized with the ability to prioritize and multi-task requests

• Good computer skills (MS Word and Excel)

• Good written and verbal communication skills

• Ability to work 1st or 2nd shift and some weekends.

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 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, 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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