Sterility Assurance Associate II
Charles River Laboratories
- Memphis, TN
- $25.97-29.33 per hour
- Permanent
- Full-time
- Work closely with the operations group.
- Partner with the QC Micro Lab to develop the clean utilities and environmental monitoring program for the site
- Establish, in conjunction with the operations function, the sites gowning strategy and cleaning and sanitization program
- Liaise with the global science and technology team to ensure best practices are in place concerning sterility assurance
- Collaborate with cross-functional teams for the transfer of microbiological test methods to the site
- Maintain site practices for contamination control etc. utilizing training and a purposeful presence on the operations floor
- Influence operations area owners to ensure that quality issues are identified, and appropriate corrective actions are implemented to maintain compliance
- Comply with the EHS&S policy and procedures and demonstrate EHS&S best practices in all work activities.
- Adhere to and follows all procedures, policies, and guidelines ensuring compliance with cGMP and HPRA/FDA regulations and company policies, procedures, and guidelines
- Perform other duties as assigned.
- Bachelor's degree in biology or relevant scientific discipline preferred
- Minimum 1-3 years relevant laboratory experience or experience in a cGMP and/or FDA regulated industry
- Demonstrated knowledge in Microbiology and aseptic techniques
- Ability to work independently or as a team member
- Detail-oriented with strong written and verbal communication skills
- Ability to problem-solve and troubleshoot as necessary
- Familiarity with laser particle counters, viable air samplers, microscope, Endosafe® Instrumentation, PCR, BacT/ALERT systems
- Demonstrated knowledge in decision based data trending and investigations for system/process improvements
- Ability to work independently or as a team member
- Detail-oriented with strong written and verbal communication skills
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 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.