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Quality Operations Specialist III
Charles River Laboratories International Inc (CRL)
Memphis, TN, US, 38118
Job Summary
This position aids in training, review of documentation, and resolving of comments as well as working closely with our clients to ensure quality products and timelines are met. With a quality mindset, .aid in various areas to help both the business and clients and support internal teams. This role is primarily a product disposition role but also supports the Quality on the floor team. |
- Review manufacturing Batch Production Records (BPRs) and associated supporting documentation including forms, Quality Control (QC) testing reports, environmental monitoring reports, etc.
- Perform reconciliation of documentation and labels
- Perform line clearance and provide general manufacturing support
- Perform Quality on the Floor in clean space as required for critical processes
- Support product shipment and receipt of returns
- Support raw material review and disposition in SAP
- Serve as owner of assigned nonconformances, CAPA, change controls, or other quality system documents and collaborate to drive completion
- Review and approve documents in electonic documentation system
- Review and respond to client comments and requests
- Attend client meetings and provide updates as required
- Prepare lot packages for disposition decision by management
- Train Level 1 and Level 2 as required
- Perform all other related duties as assigned
Job Qualifications
- Bachelor’s degree (B.A./B.S.) in biology, biochemistry, chemistry or other science related field preferred or equivalent experience in leu of education requirements.
- Minimum4 years related experience in a GMP environment. Biopharmaceutical/ pharmaceutical or related industry preferred.
- Excellent written and verbal communication skills
- Ability to prioritize daily activities in order to meet client needs within established time lines in a fast-paced environment
- Proficient in computer system use, including but not limited to Microsoft Office (Word, Excel, Power Point)
- Ability to train and delegate to other members of a team
- Prior experience with SAP a plus but not required
The pay range for this position is $63,000 - $68,000. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.
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, or 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 [email protected]. This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications.
Job posted: 2024-03-06
