Overview
On Site
$$23.57hr - $28.57hr
Contract - W2
Contract - to 12/31/2025
Skills
Technical Support Scientist
Job Details
Job Description:
Pay Range: $23.57hr - $28.57hr
Responsibilities:
Pay Range: $23.57hr - $28.57hr
Responsibilities:
- Change Control Candidateagement: Handle various document types including Candidateufacturing Procedures, Quality Control Procedures, Certificates of Analysis, Material Specifications, and occasionally Labels/Package Inserts.
- Impact Assessment: Create thorough and well-drafted change impact assessment documents, ensuring quality documents are properly redlined and in-process revisions are controlled prior to approval.
- Document Review: Conduct detailed reviews of changes for documents before submission to supervisors/approvers, ensuring all necessary documents for routing change requests are in place.
- Compliance: Ensure documentation is appropriate, justified, and approved by responsible functional areas within the timeline and in compliance with established procedures.
- Project Tracking: Assist with project management for various activities including product design history file IVDR remediation, UDI activities, and change packages.
- Utilize Smartsheet to track project progress, ensuring timely updates and efficient management of change control activities.
- Collaboration: Work with scientists to problem-solve technical documentation issues and learn the Quality System, document change control, and technical impact assessments.
- Experience with project management.
- Familiarity with Quality Systems and document change control.
- Ability to conduct technical impact assessments.
- Strong problem-solving skills and ability to collaboXX with scientists.
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