Quality Ops Specialist 3

Req ID #:  186591
Location: 

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

 

We are seeking a Quality Ops Specialist III for our Cell Therapy Manufacturing Facility located in Memphis, TN.
 
The following are responsibilities related to the Quality Ops Specialist III position:


•    Review manufacturing Batch Production Records (BPRs) and associated supporting. documentation including logbooks, Quality Control (QC) testing reports, environmental monitoring reports, etc.
•    Perform line clearance and provide general manufacturing support.
•    Supports product shipment and receipt of returns.
•    Support raw material review and disposition.
•    Review Building Management Systems reports.
•    Participate in departmental and cross-functional continuous improvement efforts.
•    Consistently set a high standard for quality of work.
•    Promote a safety mindset through daily actions and communication with team members.
•    Issue BPR and labels to Manufacturing.
•    Serve as owner of assigned nonconformances, CAPA, change controls, or other quality system documents and collaborate to drive completion.
•    Review and approve documents in Master Control.
•    Prepare lot packages for disposition decision by management.
•    Train Level 1 as required.
•    Other duties as assigned.

Job Qualifications

 

The following are minimum qualifications related to the Quality Ops Specialist III position:


•    BS/BA Life Science or related field.
•    Minimum of 4 years GMP related experience in biopharmaceutical/ pharmaceutical or related industry.
•    Experience with GMP regulatory requirements.
•    Ability to multi-task effectively.
•    Excellent written and verbal communication skills.
•    Ability to prioritize daily activities in order to meet client needs within established timelines in a fast-paced environment.
•    Proficient in computer system use, including but not limited to Microsoft Office (Word, Excel, Power Point).

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

Job Segment: Pharmaceutical, Recruiting, Laboratory, CAPA, Science, Human Resources, Operations, Management