- Job ID
- Job Locations
- Quality Assurance & Quality Compliance
More information about this job:
Ortho Clinical Diagnostics (Ortho) is a leading global provider of in vitro diagnostics. We have an established track record for providing high-quality products and services to the global clinical laboratory and immunohematology communities. Headquartered in Raritan, NJ, Ortho Clinical Diagnostics has approximately 3,800 employees, serving customers in more than 120 countries.
We are recruiting and retaining the best and brightest around the world. People who are performance driven, want to make a difference and who help us grow our leadership position in a changing marketplace. The power to reimagine starts with empowered people. People who are empowered to grow and given the chance to succeed in ways they hadn’t thought possible before.
Our purpose is simple: to improve and save lives with diagnostics. We do that by reimagining what’s possible. It’s what defines us. It’s the Ortho difference.
The Career Potential:
Ortho Clinical Diagnostics is committed to improving and saving lives with diagnostics. To do this we hire people who share this dream and are ready for new adventures. As a valued team member, you will carve your own career path and be part of building this company stronger and better than ever before. There is no limit to the experiences, opportunities and new directions you will have access to here at Ortho Clinical Diagnostics. More importantly, you will be driving the surge of a whole new direction in important medicine. That’s something we can all take pride in as we take this journey together.
The Scientist I in the Reference Laboratory assures the Calibration Traceability by executing complex analytical testing of patient samples and other fluids to support the release process, stability testing, accuracy testing, and new method development. This testing uses a variety of instrumentation including manual spectrophotometers, Olympus AU400, flame photometers, atomic absorption, RIA, GC and HPLC. The Scientist I maintains instrumentation, calibrates, runs quality control, and analyzes requested samples. Summary reports, analysis of technical data, evaluation of quality control, and instrument troubleshooting are within the scope of this position. Work is scheduled, supervised, and follows established methods and procedures. Product accuracy is dependent upon the technical ability of this individual and reproducibility of the analytical methods
- Independently analyzes analytical data for accuracy, quality control for trends, method precision, completes investigation reports, and performs release testing per documented specifications and consults with others with analytical interpretation of data.
- Independently organizes their daily workload and performs testing within established timelines following documented procedures and frequently assists others. Assigned priorities are completed, and Reference Lab projects and reagent preparations are always available.
- Drives continuous improvement and compliance through LEAN concepts, 5S, visual management and standard work. May be business owner for procedures, conducts periodic reviews to schedule, and contributes to SOP updates as required.
- Develops the capacity to become the Primary subject matter expert and trainer for the chemistry assignments.
- Initiates NCs if required and go to risk ranking meetings to represent area. Candidate will contribute the designing experiments, troubleshooting for instrumentation and reference assay accuracy issues.
- Candidate must have a demonstrated successful proven track record in an analytical or clinical laboratory setting, have a high affinity toward teamwork, and demonstrated problem solving using innovative solutions.
- Laboratory staff may represent the Reference Laboratory area in Internal Audits and External Audits as requested.
- Responsible for ensuring CAPAs, CO’s, NCs for area are completed and reported to management as requested.
- Bachelor’s Degree in Medical Technology, Chemistry, Clinical Chemistry, Biology, Biochemistry or equivalent.
- Demonstrate some laboratory environment experience.
- Familiarity with GLP and GMP practices.
- Microsoft Excel, Word and Office is required.
- Up to 5% travel may be required.
At Ortho Clinical Diagnostics, we are proud of the empowering, inclusive and innovative culture we are growing. Our team is passionate about our work, and brings deep knowledge, industry experience and diverse thinking that drive results, making Ortho a place to grow your career.
Ortho Clinical Diagnostics is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other characteristic protected by law.