- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the use of quality systems such as SAP. Experience working with cell therapy is preferred Knowledge of cGMP regulations and FDA/EU guidance related to ... seeking a QA Warehouse Incoming Raw Material Specialist as part of the Quality team...quality and operations counterparts that include Manufacturing Operations, Quality Assurance , Engineering and Validation, Quality… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …have experience working in an aseptic manufacturing facility, preferably cell therapy , testing facility, quality assurance , or manufacturing compliance ... of multiple myeloma. Legend Biotech is seeking a CQV Specialist (Contract Position) as part of the Technical Operations...and Validation support to the cGMP Clinical and Commercial Cell Therapy Manufacturing plant. This individual will… more
- BioAgilytix (Durham, NC)
- …settings, and workflows. You are the bridge between the lab and the quality assurance team, combining observations on regulatory requirements with your knowledge ... be a critical part of our beginning-to-end client data quality processes. Through your technical reviews of raw and...of plate-based assays, cell work, gene therapy and more.We are… more
- Gilead Sciences, Inc. (Frederick, MD)
- …the art, commercial cell therapy facility in Frederick, Maryland. The Experienced Cell Therapy Specialist , internally known as a Cell Therapy ... execute GMP runs in close collaboration with Materials Management, Quality Control and Quality Assurance ....we'd like to consider you! **Responsibilities of the Experienced Cell Therapy Specialist include:** +… more
- Bristol Myers Squibb (Bothell, WA)
- …to patients, there's no better place than here at BMS with our Cell Therapy team. The Quality Assurance Document Control (QADC) Labeling Specialist ... optimizing a production line to the latest breakthroughs in cell therapy , this is work that transforms...relational databases and reporting tools to collate and analyze quality data. **Knowledge & Skills:** + Strong communication and… more
- Mayo Clinic (Jacksonville, FL)
- …Analyst, FDA Regulated Manufacturing will be part of a team of four, consisting of the site QA manager, one QA specialist and two senior QA specialists. ... + Is accountable for the effective implementation of the Quality Management System (QMS) and serves as a subject...compliance, or management and 5 years' experience in a quality related field is preferred or a bachelor's degree,… more
- Editas Medicine (Cambridge, MA)
- …life science and 8+/6+ years respectively of relevant industry experience in Quality Assurance in a Pharmaceutical/Biotech GMP environment. + Experience ... management. + Exercise judgment in resolving moderate to complex quality issues. + Act as QA liaison...communication skills required. + Understanding of regulatory guidance on cell and gene therapy products. + Expertise… more
- Bristol Myers Squibb (Trenton, NJ)
- …both at work and in their personal lives. Read more: careers.bms.com/working-with-us . The Quality Assurance Specialist will help support operations through ... optimizing a production line to the latest breakthroughs in cell therapy , this is work that transforms...in a new Radiopharmaceutical facility in Indianapolis, IN. The Quality Assurance Specialist will be… more
- MD Anderson Cancer Center (Houston, TX)
- …various clinical trials that may differ from standard operating procedures of MDACC Cell Therapy Laboratory. Must adhere to all defined processing and ... patient laboratory records and prepare reports for review by laboratory directors, quality assurance and physicians. 1. Coordinate and manage supply inventory… more
- Bristol Myers Squibb (Devens, MA)
- …day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy , this is work that transforms the lives of patients, and ... in a regulated environment with 2 years focused on quality preferred. + Knowledge of biotech bulk and finished...+ Assures all electronic and paper documentation, which requires QA review is in compliance with corporate and site… more
- Bristol Myers Squibb (Indianapolis, IN)
- …day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy , this is work that transforms the lives of patients, and ... a primary contact point for quality system support. This position will utilize quality assurance knowledge in maintaining the quality program to be ready… more
- Insight Global (Morris Plains, NJ)
- …cytometry within QC manufacturing space -Solid quality -centric experience and mindset ( QA /QC) -Experience in biologic or vaccine or cell culture products ... our large pharmaceutical clients is looking to hire a Quality Specialist to join the growing External...-Experience with cell and gene therapy products -Experience with good tissue practices -Experience… more
- Editas Medicine (Devens, MA)
- …areas. + Exercise good judgment in issue identification, resolving moderate to complex quality issues, and escalations. + Act as QA liaison to site ... analysis investigations. + Demonstrated expertise understanding/interpreting regulatory guidance on cell and gene therapy products. Preferred Qualifications:… more
- Insight Global (Santa Monica, CA)
- …their team. This company develops cancer immunotherapy products with a primary focus on cell therapy based solutions. We are looking for someone with a strong ... quality background to provide T- cell and vector...and vector stability support for clinical and commercial CAR-T therapy products. This person will write stability protocols and… more
- Bristol Myers Squibb (Phoenix, AZ)
- …day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy , this is work that transforms the lives of patients, and ... + Collect and enter data into electronic data management systems + Work with Quality Assurance and other internal business partners to monitor and assess vendor… more
- WuXi AppTec (Philadelphia, PA)
- …and rapid completion for in support of in-process testing and/or rapid release Cell Therapy products. * Accurately completes Test Methods and other required ... consumables as required. * Completes all requisite training (ie Bloodborne Pathogen, Quality Assurance , safety, etc.) * Correctly analyzes scientific data with… more
- UCLA Health (Los Angeles, CA)
- …The CLS Specialist tasks are identified with an asterisk (*). CLS Specialist participates in quality assurance by performing audits, investigating and ... Job duties include but are not limited to: + cell therapy product processing + preparing reagents...therapy product processing + preparing reagents + performing quality control and calibration for test systems + maintaining… more
- Gilead Sciences, Inc. (Santa Monica, CA)
- …that include Analytical Development, Process Design, MSAT (Manufacturing Science and Technology), Quality Assurance , Quality Control (local and global), ... day-to-day work. This senior level technical experienced professional will provide product quality support that focuses on regulatory writing of BLA sections for… more
- WuXi AppTec (Philadelphia, PA)
- …+ Medical, dental and vision insurance + and much more The **Supplier Quality Specialist ** executes qualification, maintenance, and monitoring for WuXi suppliers ... preferred **Knowledge/Skills/Abilities:** + Thorough working knowledge of Regulatory Compliance, Quality System Management and Quality Assurance … more
- University of Colorado (Aurora, CO)
- …City, State. As an academic based biotechnology company, ClinImmune Cell & Gene Therapy is committed to providing the highest quality service and support to ... | Division of Allergy & Clinical Immunology | ClinImmune Cell & Gene Therapy ** **Official Title: Healthcare...well with others and independently. + Actively participate in quality assurance program. + Record results accurately… more