Description:
Exempt/Non Exempt: Non ExemptYears Experience: 1 year or advanced degree(s) may offset required years of experienceSkills: Prefer Clinical Chemistry analyzer testing experience. Knowledge of GMP, ISO and FDA regulations is desirable. Education: Bachelor's degree in scientific or technical fieldDuties: Provide technical support for diagnostic products. Develop and design experiments, perform testing on Clinical Chemistry instruments, analyze data and summarize results.
Job Responsibilities:
We are seeking a dedicated Change Control Specialist to join our Technical Product Support team.
This position will be primarily responsible for initiating and managing change control packages for device master records to support product end-of-life documentation and supplier change notifications, as well as project managing various activities including product design history file IVDR remediation, UDI activities, and change packages.
Key Responsibilities:
Change Control Management: Handle various document types including Manufacturing 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.
Qualifications:
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 collaborate with scientists.
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