Quality Control Associate
Northridge, CA, US, 91325
For over 40 years, Charles River Cell Solutions has worked to making a positive impact on the world by providing the highest quality cellular material and services to biotech and pharmaceutical companies and research organizations that are performing innovative research and developing novel cell-based therapies.
We recognize that our success depends on the vision and passion of our employees; that is why we are devoted to making Cell Solutions a rewarding and valuable place to work. We believe in making a difference, and at Cell Solutions, you will make a difference every day.
Job Summary
The QC Associate I supports the Quality Control Manager to maintain the Quality Control program at Cell Solutions Charles River Laboratory, Northridge. The QC Associate will be responsible for performing Quality Control testing of samples/materials generated during the manufacturing of all cryopreserved products, perform microbiological Environmental Monitoring of Cell Processing/Clinical Labs as well as activities covering the inspection, sampling and testing of incoming raw materials.
Essential Responsibilities:
- Perform post-thaw analysis of QC materials generated during manufacturing of cryopreserved products
- Perform Environmental Monitoring in the Cell Processing and Clinical Lab as well as read and record/enter all Environmental Monitoring data and results into a database.
- Initiate deviations and perform investigations of Environmental Monitoring excursions
- Aid in the initial inspection of incoming raw materials as well as perform critical material testing as required
- Assist in creation, review and revision of Standard Operating Procedures (SOPs) and other relevant documents.
- Perform Quality Control and preventative maintenance on laboratory equipment as assigned. Maintain records in compliance with regulatory guidelines
- Ability to identify and aid in the investigation of out of specification results, deviations and Corrective and Preventive Actions (CAPAs).
- Identify and troubleshoot problems encountered in assigned tasks and properly document corrective actions. Confer with supervisor for resolution of problems
- Review the QC components of the batch records.
- Responsible for raw material inventory management and removal of expired materials from the QC laboratory
- Maintain specification documentation for materials within the Cell Processing, Clinical, and QC laboratories.
- Submit/ prepare shipments of samples to external groups for testing which includes, but is not limited to: Sterility, Endotoxin, Mycoplasma and Environmental Monitoring identification
- Able to read, interpret, and understand company and industry manuals and compliance standards such as Standard Operation Procedure manuals, Current Good Manufacturing Practices, FDA, UE, and AABB regulations
- Knows and follows safety rules relative to area(s) or responsibility. Follows Standard Operating Procedures (SOPs) and Current Good Manufacturing Practices (cGMPs) and external regulations regarding the products and procedures
- Any duties as deemed necessary and as assigned.
Job Qualifications
- AA or BS degree in Life sciences preferred.
- A minimum of 0-2 years of laboratory experience in a commercial QC incoming inspection, sampling and testing environment.
- Familiar with laboratory equipment, such as pH meter, cell counter and Flow Cytometer.
- Working knowledge of cGMP, GDP, and GLP preferred.
- Experience with laboratory information management systems (LIMS).
- Highly collaborative with the proven ability to work in a cross-functional team.
- Proficient use of Microsoft Office products, including Word, Excel, Outlook, and PowerPoint.
- Able to use/maintain medical and scientific lab equipment performance.
Compensation Data
The pay range for this position is $47,000-58,100. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.
About Charles River Cell Solutions
Charles River Cell Solutions is a global leader and trusted brand in the customization of human-derived biological products and services for biomedical research, drug discovery, and cell and gene therapy development. Cell Solution’s vertically integrated solutions support preclinical research, clinical studies from phases 1 to 3, and commercialization with high-quality RUO and GMP-compliant starting material and apheresis collections.
In January 2020, HemaCare was acquired by Charles River Laboratories, an early-stage contract research organization (CRO). Combined with Charles River’s integrated, early-stage portfolio of discovery, safety assessment, and manufacturing support services, the acquisition creates a unique, comprehensive solution for researchers and cell therapy developers and manufacturers worldwide to help accelerate their critical programs from basic research and proof-of-concept to regulatory approval and commercialization. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs and enhances their productivity and effectiveness to increase speed to market. We work closely with our clients throughout the clinical process to maximize success and drive positive clinical outcomes.
Together, 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 and biotechnology companies, government agencies, and hospitals and academic institutions around the world.
At Cell Solutions, we are passionate about our role in improving the quality of people’s lives. We have proudly supported the development of 100% of the current commercially available FDA-approved immunocellular therapies. Our mission is to provide a best-in-class portfolio of high quality, customizable human cellular material and services to support drug discovery, scientific research, and cell therapy. This resonates from our employees and impacts our customers because we know that every day is an opportunity to advance discoveries and make a difference in someone’s life.
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 [email protected] 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: Los Angeles
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