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Lab Technician - 53569143 - MG

Job Code: 53569143
Job Location: Fridley, MN
Category: Technicians
Last Updated: 10/06/2016
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Job Description:
POSITION RESPONSIBILITIES:
• Material Characterization for Biocompatibility and Toxicological Assessments
o Prepares samples for extraction and leachable testing per ISO 10993.
o Sets up extraction and completes sample analysis form.
o Performs the extraction and collection of subsequent extract solutions.
o Complete the nonvolatile gravimetric residue analysis.
o Send out sample extracts to secondary lab for analysis if needed (ICP-MS).
o Train and follow all laboratory SOPs and Work Instructions (WI).
• Biological Testing
o Perform sample preparation for ELISA and other biological analysis.
o Train and follow all laboratory SOPs and Work Instructions (WI).
Other responsibilities include:
• Regulations
o Under the guidance of the study director, reviews Preclinical study data intended for regulatory submissions for compliance to Good Laboratories Practices, and interfaces with quality assurance, regulatory committees (e.g. IACUC), and Regulatory Affairs regarding requirements and results of the study.
o Reviews submissions to regulatory bodies for correlation and traceability to preclinical data, and compliance to the FDA Good Laboratories Practices for Non-clinical Studies.
 
Requirements:
EDUCATION REQUIRED: (No equivalencies)
Associate’s degree or Bachelor’s degree in biological sciences or related medical/scientific field.  
• Experience working in a preclinical clinical, or regulated environment.
• Familiarity with ISO 10993 standards, biocompatibility, and/or regulatory submissions  
SPECIALIZED KNOWLEDGE REQUIRED (Needs to be objective, relevant, and non-comparative)
• Demonstrated ability to effectively support a cross-functional team when necessary.
• Advanced written and oral communications skills.
• Able to manage multiple tasks.
• Proficiently broad knowledge of medical terminology and scientific principles.
• Functional knowledge of GLP and regulatory compliance guidelines, and the regulatory environment.
 
For more information about this position, please contact the Entegee New Hope, MN office at 763-577-9000 or techteam@entegee.com.
 
Please reference job # 53569143MG
 
Equal Opportunity Employer
Minorities/Women/Veterans/Disabled
 
 
 

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Entegee is an equal opportunity employer. Entegee considers applicants for all positions without discrimination on the basis of race, color, religion, sex, national origin, age, marital or veteran status, disability, or any other legally protected status. No question in the website is used for the purpose of limiting or excluding any applicant's consideration for employment on any basis prohibited by local, state, or federal law.

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