QA Release Specialist III
Charles River Laboratories International Inc (CRL)
Memphis, TN, US, 38118
Job Summary
The QA Release Specialist III is responsible for performing various Quality Assurance activities related to the disposition of incoming materials working closely with other departments including Manufacturing, Materials Management, and Supply Chain. Must be able to meet the physical requirements established in the job description. The Memphis site is a CDMO cell therapy manufacturing site.
- Responsible for disposition of incoming raw materials
- Review executed raw material specifications and associated data for compliance to requirements
- Participate in deviation events and investigations, as required
- Provides support to audits and inspections, when needed
- Assist in the onboarding and training of level I and II personnel
- Continuously seek process and compliance improvements
- Effectively prioritize daily activities to meet client needs on time of established timeliness in a fast-paced environment
- Comprehend current Good Manufacturing Practices, regulatory, and quality standards
- Identify, communicate, and escalate basic technical issues identifying possible resolution
- Assist in preparation of area for inspection readiness
- Partner and collaborate with other departments
- Complies with all departmental and company-wide SOPs
- Proactive compliance with job safety procedures, attendance of required health and safety trainings, and prompt reporting of actual and potential accidents and injuries
- May occasionally commute between two buildings (warehouse and manufacturing site)
- Clean room gowning may be required
- Perform all other related duties as assigned
Job Qualifications
- Bachelor’s Degree in biology, biochemistry, chemistry or other science related field preferred; Equivalent experience in leu of Bachelor’s Degree.
- Minimum 3 year of Good Manufacturing Practices (GMP) or related experience in related industry preferred.
- Knowledge of quality processes, including material disposition, change control, product complaints, deviations, investigations, and CAPA management.
- Must be skilled in planning and organizing, decision-making, and building relationships.
- Proficient use of Microsoft Office products, including Word, Excel, Outlook, and PowerPoint
- Able to effectively multi-task and problem solve
- Excellent written and verbal communication skills
The pay range for this position is $58,000 - $64,000. 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: 2024-03-19
