Sr. Scientist – Quality Control
Are you the right scientist to work in a fast paced manufacturing environment with cross-functional focus? Would you enjoy working on a team developing one culture based on trust, accountability, ownership, and world class performance? We are looking for a candidate who will be involved in supporting a newly established reagent manufacturing system as well as future integration projects within an Immunoassay product line. Come join our team and embrace the Siemens belief of “Know now, live better…”
- Performs routine to complex tests and analyses according to established procedures.
- Performs release activities and inputs associated data into SAP.
- Performs complex tests or investigations pertaining to the development of new designs, methods, materials, or processes and investigates possible application of results.
- Troubleshoots and resolves complex problems.
- Completes a wide variety of complex technical assignments.
- Obtains, correlates, and analyzes technical information needed to accomplish complex tasks.
- Performs mid to complex analysis of raw data to determine experimental results and learns and implements best practices for data analysis.
- Completes the preparation of reports, charts, graphs, and other documents and advises senior staff.
- Reviews and approves related inputs such as complex drawings and specifications prepared by technical support personnel.
· Plans with support mid-complex to highly complex experiments, including planning reagents and consumables required.
· May lead meetings when assigned to continue projects- either for scheduling, troubleshooting, or status collection.
· Leads development of assay parameters (test methods) for use on analytical instrumentation.
· Participates in Design Control activities: Verification and Validations, testing and documentation- from Design Change documentation to authoring protocols and reports with some support as required.
· Works collaboratively in a cross-functional team of Engineers, Manufacturing and Scientists from multiple groups.
Required Knowledge/Skills, Education, and Experience
· B.A. or B.S. Degree in biology or biochemistry with over 6 years of industry experience. Masters with 4 years industry experience. PhD with 2 years industry experience.
· Thorough understanding of 21 CFR Part 820 regulations and ISO 13485 standard requirements, and all other MDSAP country regulations for medical device or pharmaceutical operations.
· Multiple years of experience with multiple reagent kits for immunoassay based technologies, specifically involving a troponin assay.
· Experience working with analytical instrumentation, reagent systems, including testing repetitively.
· Experience planning experiments with multiple variables – may have been DOE. This includes identifying all factors and determining replicates needed for statistical significance.
· Experience identifying and troubleshooting process, material, or equipment problems to minimize down time and recommend solutions.
· Experience performing data analysis as well as formal report writing.
· Experience creating and modifying testing protocols and supporting documents.
· Familiar with statistical analysis tools.
· Familiar with working in SAP.
· Able to work independently and manage tasks assigned on schedule.
· Strong scientific, communication and organizational skills are a must.
· Should be comfortable with handling bio-hazardous materials.
· Travel required may be 0-20% depending on Project.
· Experience with multiple reagent kits for immunoassay based technologies.
Organization: Siemens Healthineers
Company: Siemens Healthcare Diagnostics Inc.
Experience Level: Mid-level Professional
Job Type: Full-time
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