Scientist I

The Scientist I will work as a member of the Mishawaka QCElaboratory group. The purpose of this position is to support all QCE laboratoryfunctions. The Scientist will be required to perform routine testing activitiesin the quality control laboratory supporting Manufacturing needs to ensuretimely delivery of quality products to our customers.

This position is a Quality Control function in which theScientist will work with a team of scientists to ensure timely release ofintermediate and finished good products. This facility manufactures andreleases products related to the Siemens Diabetes and Urinalysis medical deviceproduct lines. Assurance of compliance with all regulatory standards andregulations as well as compliance with all corporate policies and guidelines isrequired.

Major Job Responsibilities

• Performsa wide variety of assignments according to established procedures, includingbut not limited routine and moderate tests/analyses, data review and analysis,as well as panel and solution preparations
• Completespreparation of product release reports
• Reviewsdocumentation generated by the lab prior to release to ensure accuracy andcompleteness
• Providesinputs used for the purpose of control charting and trending of data collectedthrough the release process
• Ensurescompliance of current procedures and processes and as needed reviews andupdates documentation
• Communicatesissues encountered in the lab to initiate the investigation phase as well asaids in troubleshooting process with the lab supervisor
• Participationin validation activities for equipment qualifications and processimplementations
• Completesaudit of lab instrumentation
• Ensureslab inventory tracking is up to date and orders supplies as needed

RequiredKnowledge/Skills and Experience

• Experience working with analyticalinstrumentation, reagent systems, including testing repetitively.
• Experience performingdata analysis and some familiarity with statistical analysis tools.
• Experience withimmunoassay-based technologies.
• Comfortable inhandling of bio-hazardous materials.
• Well-developed written and verbalcommunication skills
• Solidinterpersonal and collaboration skills
• Ability to work in a fast paced environment, workingwell independently or in a team environment
• Typically1-2 years of successful experience in quality processes and knowledge ofquality related processes and systems
• Knowledgeable of21 CFR Part 820 regulations and ISO 13485 standard requirements
• Generalknowledge of process validation

Education
BS in chemistry or biology or equivalent combination ofeducation and experience.