- Title: Technical Support Scientist
- Code: RCI-83774 / 04591
- Location: Lake Forest Illinois (IL) 60045
- Posted Date: 08/10/2020
- Duration: 12 Months
- Name:Sumit Rawat
- Email: firstname.lastname@example.org
- Phone: 908-704-8843 ✖ 232
Primary Job Function:
- Independently manage complex; long-duration projects, product improvements and investigations.
- Proactively identify opportunities for significant operational; process; or product improvements.
This scientist position will support the regulatory submission of 200 current on-market products under the new In Vitro Medical Device Regulation (IVDR) before May 26, 2022 so that the products can continue to be sold in the European Union (EU).
Core Job Responsibilities:
Responsible for implementing and maintaining the effectiveness of the quality system.
- Project Management - Independently design; manage; and conduct complex long duration projects; product improvements; and
investigations (or supports Third Party Manufacturer projects).
- Product and Process Improvement - Independently manage complex long duration projects; product improvements; and investigations.
- Recognizes opportunities and proposes novel ideas for significant operational; process or product improvements.
- Proactively identify opportunities for significant operational; process or product improvements.
- Perform or support test and process method modifications; considering CQAs; critical process parameters and analytical performance characteristics.
- Identify technical alternatives and make risk based decisions within the area.
- Use technical data that interacts with multiple areas and processes.
- Provides diverse; independent technical data and insight to support risk management evaluation and assessment.
- Design Control & Risk Management - Effectively balances compliance risk and business risk to create and review risk management files. Will be responsible for updating existing risk management documents and reviewing TPM risk management documents for compliance to IVDR.
- Complaint and Internal Investigations - Independently manages complex investigations to resolution. Demonstrates advanced statistical
techniques; MAIC and or project management tools. Provides audit inputs and support as required.
- Technical Support - Assist in resolution of multiple complex technical and quality issues across ADD Sites; TPMs and or functions
(instrument; reagents; software and commodities). Anticipate; recognize and resolve technical issues. Will be responsible for utilizing program strategies to close product gaps prior to submission, address information requests from regulatory bodies, and maintain alignment of technical documentation and labeling across and TPM sites.
- Sharing Knowledge - Presents complex technical information to internal and external groups. Shares scientific information and expertise
with customers and regulatory agencies. Experience mentoring and teaching others to facilitate timely resolution of product and process
- Strategic and Results Orientation - Demonstrates fiscal responsibility through actionable recommendations and accomplishments.
Translates top-level goals to specific goals and aligns activities with respective strategic business priorities
- Works well in a team and is a strong individual contributor.
- Experience with Design Verification and Validation Processes
- Technical experience with ARCHITECT and Alinity, Clinical Chemistry and Immunoassay products
- Experience with Risk Management
- Strong technical background and good verbal and written skills
- Time management, organization, and self-motivation a must.