- 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
- Aequor (Seattle, WA)
- …communication - Experience working cross-functionally Position Summary: The Quality Assurance Document Control (QADC) Associate Specialist supports the cGMP ... Document Control operations for the Client Cell Therapy Above-site organization, including the document...for the site. Generate document management system reports for Quality Council metric reporting. Support internal and external audits… 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
- MD Anderson Cancer Center (Houston, TX)
- **SUMMARY** The primary purpose of the Quality Assurance Specialist (QAS) IV position is to manage the department of Stem Cell Transplantation and ... Cellular Therapy (SCTCT) Cell Therapy Laboratory (CTL) Quality Management Plan and...Investigators. c. Responsible for clinical trial final product release. ** Quality Assurance ** a. Management of Event Tracking… more
- Bristol Myers Squibb (Summit, NJ)
- …new hope to patients, there's no better place than here at BMS with our Cell Therapy team. The ** Specialist ** works cross-functionally to execute validation ... optimizing a production line to the latest breakthroughs in cell therapy , this is work that transforms...but will routinely support project and production works. The Specialist will partner with site Business Owners, CI Owners,… more
- Bristol Myers Squibb (Bothell, WA)
- …to patients, there's no better place than here at BMS with our Cell Therapy team. Our Quality Assurance and Compliance organization is pivotal 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… more
- UCLA Health (Los Angeles, CA)
- …limited to: * Maintain Quality System Essentials throughout an active Cellular Therapy program, Hemapheresis Unit and Stem Cell lab operation * Ensure ... and compliance program within the Bone Marrow Stem Cell Lab, Hemapheresis Unit and Hematologic Malignancies/Stem Cell...QA and compliance unit * Activities of a quality program include: o Development, maintenance, review and approval… more
- Abeona (Cleveland, OH)
- Position Overview The Specialist I, Quality Assurance - Operations performs routine activities associated with manufacturing of cell and gene therapy ... management ensuring procedural and regulatory compliance throughout the manufacturing process. The Specialist , Quality Assurance - Operations will report to… 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
- Kelly Services (Louisville, CO)
- ** Quality Assurance Specialist - Louisville, CO** Type: Contract (6 months, potential for extension) Shift: M-F 8a-5p Pay Rate: $37-$45/hr **Job ... manufacturing facility startup and/or operations environment. + Experience in cGMP cell and gene therapy manufacturing and/or testing facility. **Physical… more
- Charles River Laboratories (Memphis, TN)
- … QA Release Specialist III is responsible for performing various Quality Assurance activities related to the disposition of incoming materials working ... QA Release Specialist III Req ID #:...the job description. The Memphis site is a CDMO cell therapy manufacturing site. + Responsible for disposition… more
- System One (Seattle, WA)
- Job Title: Quality Assurance Document Control (QADC) Associate Specialist Location: Seattle, WA Type: Contract Overview Leading Pharmaceutical company ... looking for an experienced QA Document Control Specialist . Ideal candidates should...Responsibilities + Managing an electronic document system for the Cell Therapy Above-Site which includes reviewing and… more
- United Therapeutics (Eden Prairie, MN)
- …to help patients with liver and kidney disease. How you'll contribute The Senior QA Specialist - GMP Manufacturing, is responsible for supporting quality ... during GMP clinical manufacturing of bioengineered organs at Miromatrix. The Senior QA Specialist collaborates with and provides support for end-to-end clinical… more
- System One (Philadelphia, PA)
- Title: Senior QA Specialist - Supplier Quality ...are maintained throughout the cell and gene therapy manufacturing process. The QA Specialist ... benefits package Start date: Immediate Overview: Join our dynamic team as a QA Specialist - Supplier Quality for a Contract Development and Manufacturing… 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
- Astellas Pharma (Westborough, MA)
- …is an onsite position. **Purpose and Scope:** This member of the Quality Assurance team will perform critical QA compliance tasks in support of GMP ... and induced pluripotent stem cells as well as other cell -based therapy research programs. AIRM is headquartered...The Compliance Specialist reports to a Associate Quality Assurance Manager or Quality … more
- Astellas Pharma (Westborough, MA)
- …Integrity. **Organizational Context:** + The Compliance Specialist reports to a Associate Quality Assurance Manager or Quality Assurance Manager, who ... and induced pluripotent stem cells as well as other cell -based therapy research programs. AIRM is headquartered...in turn reports to the Director of Quality Assurance . Quality … 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 (Cambridge, 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
- Bristol Myers Squibb (Trenton, NJ)
- …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
