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QC Operations Specialist II

Employer
Charles River Laboratories
Location
Memphis, Tennessee, US
Salary
Competitive
Closing date
Jan 15, 2022

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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 Operations Specialist II for our Cognate BioServices site located Memphis, TN. The role requires strong attention to detail, good problem-solving skills, and critical thinking to complete daily tasks.

The following are responsibilities related to the QC Operations Specialist II:

  • Support onboarding and training QC Operation Specialist, I
  • Identifies and initiates continuous improvement efforts applicable to QC Operations processes.
  • Receives and reviews results from QC Analytical group for completeness and accuracy.
  • Data entry into QA metric logs, reviewing electronic data entries.
  • Recognize GDP and calculation errors in QC documentation, and ensure the correction of those errors.
  • Data entry of product analytical test results in QC tracking and trending spreadsheets/software.
  • Comprehend QC assay procedures, calculations, and expected documentation practices to enforce compliance through peer review of completed documentation.
  • Receive, check-in and dispose of samples according to established guidelines and SOPs.
  • Complete all appropriate paperwork according to relevant SOPs and standard lead times.
  • Identify, document, and resolve all discrepancies between department paperwork and sample vials.
  • Accessions specimens using automated and manual systems.
  • Monitor proper storage of samples.
  • Reconciles QC inventories with logs including annual review of QC retains.
  • Organizes and ships QC test samples to subcontracted laboratories or clients.
  • Completes training on procedures to ensure that tasks are conducted in accordance with established protocols, SOPs, GLPs, and other pertinent regulatory requirements.
  • Notifies supervisor of sample quality issues and documents appropriately.
  • Maintain an organized document review system.
  • Assist in compiling QC data packets when needed.
  • Assist with document and record control functions as needed.


Job Qualifications

The following are minimum qualifications related to the QC Operations Specialist II position:

  • Bachelor's or higher degree in a science related field, or a minimum of 3 years of experience in a cGMP lab environment.
  • Strong attention to detail and problem-solving skills.
  • Strong math skills and demonstrated knowledge of life sciences.
  • Knowledge of GDP, GMP, and GLP.
  • Very organized with the ability to prioritize and multi-task requests.
  • Must possess initiative to seek resolution to a problem and utilizes teamwork and good communication to collaborate on solutions.
  • Good computer skills (MS Word and Excel).
  • Good written and verbal communication skills.

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.
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