- Terumo Medical Corporation (Elkton, MD)
- …Medical Corporation is comprised of two strategic business divisions: Terumo Interventional Systems and Terumo Medical Products. We believe that the future is bright ... plans. Lead in implementation of quality assurance plans, process controls, and CAPA systems designed to meet or exceed internal and external requirements. 4. Acts… more
- BeOne Medicines (Pennington, NJ)
- …intermediates and finished biological products (monoclonal antibodies) under FDA /EU regulations, applicable International Regulations, and BeOne Medicines' processes ... preventive actions (CAPAs). + Participate in transfer and method validation activities, including protocol preparation, protocol execution, and report preparation.… more
- BioBridge Global (San Antonio, TX)
- …develop testing procedures according to organizational and regulatory (NMDP, AABB, FACT, ISO, FDA , and cGMP) standards. Assist with validation of all procedures ... advanced therapies. Leveraging its showcase facility designed to be compliant with FDA , EMEA, and PMDA production requirements, BBG Advanced Therapies focuses on… more
- Abbott (Sylmar, CA)
- …What You'll Work On + Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to ... requirements + Lead in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements + Assist in… more
- Cardinal Health (Indianapolis, IN)
- …procedures. Generate study reports where required. + Complete equipment qualification and computer system validation protocols developed in partnership with ... sensitive radiopharmaceuticals in an integrity driven, highly regulated environment (ie FDA , NRC, DOT) to support patient treatment through disease diagnosis,… more
- Abbott (Irving, TX)
- … or instrument control. + Strong understanding ofsoftware validation ,code reviews, andquality assurancepractices. **Preferred Qualifications:** + Experience in ... the globe. The crucial information derived from our tests, instruments, and informatics systems is often the first step in patient care decision-making for hundreds… more
- United Therapeutics (Morrisville, NC)
- …testing activities for remediation activities, new project/product support (development, validation , etc.), implementation/maintenance of laboratory systems such ... pulmonary arterial hypertension ( **PAH** ). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung… more
- Abbott (Houston, TX)
- …and providing quality engineering support within manufacturing, or system /services support. **_MAIN RESPONSIBILITIES_** + Identify and implement effective ... process control systems to support the development, qualification, and on-going manufacturing...design engineering in the completion of product verification and validation + Work with microbiology to ensure appropriate environmental… more
- Actalent (Fort Lauderdale, FL)
- …study, analyze, and learn details of designs, construction, and operation. Documents systems including testing and validation . + Applies understanding of ... C++, Assembly Familiar with: GUI Zero, QT framework, OpenCV Experience in camera system , image processing, computer vision Experience in medical device domain… more
- University of Miami (Miami, FL)
- …schedules to ensure efficient management of resources and workflow. + Test Method Validation : ensures testing systems provide quality laboratory services for all ... Proficiency: Skilled in using office software, technology, and relevant computer applications. + Communication: Strong verbal and written communication skills… more