Neel Patel
Des plaines
Summary
Analytical Quality Control Analyst with background in implementing and enhancing quality assurance processes. Skilled in data analysis, regulatory compliance, and process improvement to ensure product reliability and consistency. Proven ability to lead cross-functional teams in identifying discrepancies and developing corrective actions that significantly reduce errors and increase customer satisfaction.
Overview
1
1
year of professional experience
1
1
Certification
Work History
Post Market Quality Assurance Specialist I
Abbvie
North Chicago
11.2024 - Current
- Managed product complaint documentation, investigations, and identification of potential adverse and reportable events.
- Product complaint documentation, investigation, and review of all non-medical complaint content. Responsible for reviewing medical complaints that involve a non-medical quality-related problem. Provide quality customer service through the coordination of return samples for investigation, and follow-up activities such as the replacement of the product.
- Ensured that complaint documentation meets Good Documentation Practices, as well as GMP and GCP. This requires good analytical skills, technical writing, and good documentation. Ensure that complaint files meet all regulatory requirements.
- Identification of potentially reportable events, and notification to appropriate functional groups and management.
- Interface with third-party manufacturers, health care professionals, the general public, internal customers, client functional areas, and regulatory agencies.
- Working with internal and external audits to ensure records are in compliance, and in good regulatory standing. For both medical devices and combination products.
- Collaborated with cross-functional teams to address quality issues.
- Reviewed and updated standard operating procedures for accuracy.
- Utilized quality management systems to track compliance and deviations.
- Assisted in training staff on quality assurance protocols and practices.
- Analyzed data to identify trends and areas for improvement in processes.
Molecular Technologist l
Tempus AI
Chicago
08.2024 - 11.2024
- Work with a cutting-edge genomics workflow to provide high-quality next-generation sequencing data, with rapid turnaround times, in a clinical laboratory.
- Performed routine testing, quality control, calibration, maintenance, and proficiency testing in accordance with current laboratory procedures. Performed complex molecular-based procedures with a high degree of quality and in accordance with established protocols.
- Perform next-generation sequencing, including nucleic acid extraction, DNA/RNA quantification and qualification, NGS library preparation, probe hybridization, probe/library capture, library cleanup and quantification, and loading sequencing libraries onto the Illumina NextSeq, HiSeq 4000, and NovaSeq.
- Sterilizing laboratory equipment and workspaces, as assigned.
- Entering clinical patient data into the Laboratory Information Management System.
- Maintain competency to perform all assigned molecular biology protocols in accordance with CAP, CLIA, and NYSDOH regulations.
Education
Bachelor of Science - Biology- Major
Loyola University Chicago
Chicago, IL05.2024
Skills
- Microsoft applications
- Verra Vault
- Salesforce
- Compliance Wire
- SAP
- Product complaint management
- Quality assurance protocols
- Regulatory compliance
- Cross-functional collaboration
- Attention to detail
- Problem solving
- Technical documentation
- Production optimization
- Internal audits
Certification
- Pharmacy technician license
- CNA
Timeline
Post Market Quality Assurance Specialist I
Abbvie
11.2024 - Current
Molecular Technologist l
Tempus AI
08.2024 - 11.2024
Bachelor of Science - Biology- Major
Loyola University Chicago