New Research Associate Job in Round Lake, IL!
Position Title: Research Associate

Position Number: 341862

Location: Round Lake, IL 60073

Position Type: Temporary

Required Skill Set:

FDA, Pharmaceutical, Research

Position Description:

**C2C is not available**
**Only U.S. Citizens and those authorized to work in the U.S. can be considered as W2 candidates.**
Job Title: Research Associate
Start Date: 07/27/2020
End date: 12/31/2020
Location: Round Lake, IL 60073



Summary: This position will support chemical characterization of medical devices through sample management, data management, verification and document generation extractables studies, assessments, and generation of materials for submission to meet the regulatory compliance timing for EU-MDR. Essential Duties and Responsibilities: 1. Manage activities for medical device compliance to new regulatory standards using an understanding of state-of-the -art chemical characterization (10993:18) requirements.
2. Write extractables and leachables assessments and rationales for medical devices.
3. Write protocols reports, procedures, gap assessments, and data summaries.
4. Manage sample and testing scheduling associated with EU-MDR project milestones
5. Evaluate analytical results, identify trends and exceptions.
6. Perform calculations required for E&L testing (e.g., unit conversions)
7. Data management (transcription and verification).
8. Routinely consult and assist team members regarding problems and project work .
9. Evaluate results relative to product requirements, definitions and/or project goals.
10. Maintain knowledge of relevant QSR and other regulatory requirements related to R&D (product development, design and safety) to ensure compliance in all research, data collection and reporting activities.
11. In addition to having an in-depth knowledge and understanding of cGxP and related regulations and guidance, is able to provide expert advice and/or is an active participant in the generation, review, adoption and interpretation of such regulations.
Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. List knowledge, skills, and/or abilities required. • Attention to detail
• Good working knowledge of scientific terminology, medical, pharmaceutical and research concepts
• Experience with extractables and leachables testing and Elemental Impurities
• Experience with techniques including GC/MS; LC/MS and ICP-MS
• Relevant technical writing and computer skills
• Flexibility and can shift gears comfortably
• Ability to objectively assess, organize, and clearly communicate complex information
• Interpret available information and make recommendations to resolve technical challenges
• Appropriately prioritize assignments to meet project schedules
• Good knowledge of word processing, spreadsheets, table and graph generation and use of applicable computer software
• Working knowledge of industry regulations MDR, ICH, GxP, or other regulated environments
• Effective written and oral communication skills
• Ability to work well in a collaborative team environment
Education and/or Experience: Include the education and experience that is necessary to perform the job satisfactorily.
Bachelor degree in relevant scientific discipline (chemistry, pharmaceutical sciences) with 5-7 years’ experience or Masters’ degree with 3-5 years’ experience or PhD with 0-3 years’ experience. Research lab experience may include research in GMP/QSR environment, cross-functional teamwork, and independent experimentation in method development and validation.
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Rose International is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender (expression or identity), national origin, arrest and conviction records, disability, veteran status or any other characteristic protected by law. Positions located in San Francisco and Los Angeles, California will be administered in accordance with their respective Fair Chance Ordinances.

Rose International has an official agreement (ID #132522), effective June 30, 2008, with the U.S. Department of Homeland Security, U.S. Citizenship and Immigration Services, Employment Verification Program (E-Verify). (Posting required by OCGA 13/10-91.)
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