Scientist 1

Position Title: Scientist 1
Client: Siemens Healthcare
Job ID: SIMNJP00053452
Duration: 12 months
Job Location: Mishawaka, IN
Job Description:
The Scientist I will work as a member of the QCE laboratory group. The purpose of this position is to support all QCE laboratory functions. The Scientist will be required to perform routine testing activities in the quality control laboratory supporting Manufacturing needs to ensure timely delivery of quality products to our customers. 

This position is a Quality Control function in which the Scientist will work with a team of scientists to ensure timely release of intermediate and finished good products. This facility manufactures and releases products related to Diabetes and Urinalysis medical device product lines. Assurance of compliance with all regulatory standards and regulations as well as compliance with all corporate policies and guidelines is required. 

The Scientist I will work as a member of the Northern Indiana QCE laboratory group. The purpose of this position is to support all QCE laboratory functions. The Scientist will be required to perform routine testing activities in the quality control laboratory supporting Manufacturing needs to ensure timely delivery of quality products to our customers. 

This position is a Quality Control function in which the Scientist will work with a team of scientists to ensure timely release of intermediate and finished good products. This facility manufactures and releases products related to the Siemens Diabetes and Urinalysis medical device product lines. Assurance of compliance with all regulatory standards and regulations as well as compliance with all corporate policies and guidelines is required. 

Major Job Responsibilities 
Performs a wide variety of assignments according to established procedures, including but not limited routine and moderate tests/analyses, data review and analysis, as well as solution preparations 
Completes preparation of product release reports 
Reviews documentation generated by the lab prior to release to ensure accuracy and completeness 
Provides inputs used for the purpose of control charting and trending of data collected through the release process 
Ensures compliance of current procedures and processes and as needed reviews and updates documentation 
Communicates issues encountered in the lab to initiate the investigation phase as well as aids in troubleshooting process with the lab supervisor 
Participation in validation activities for equipment qualifications and process implementations 
Completes audit of lab instrumentation 
Ensures lab inventory tracking is up to date and orders supplies as needed 

Required Knowledge/Skills and Experience 
Ability to discern colors based on visual color product testing requirements 
Well-developed written and verbal communication skills 
Solid interpersonal and collaboration skills 
Ability to work in a fast paced environment, working well independently or in a team environment 
Proficient in Windows-based applications including Microsoft Access and Minitab Statistical Software 
Typically 1-2 years of successful experience in quality processes and knowledge of quality related processes and systems 
Knowledgeable of 21 CFR Part 820 regulations and ISO 13485 standard requirements 
General knowledge of process validation 

Education 
BS in chemistry or biology or equivalent combination of education and experience

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