Chelsea Centeio
Marlborough,USA
Summary
Results-driven Compliance Risk Analyst at TJX with expertise in quality assurance and compliance documentation. Proven ability to lead cross-functional teams, enhancing operational efficiency and reducing data redundancy. Skilled in ISO standards and root cause analysis, ensuring adherence to regulations while fostering a culture of continuous improvement.
Overview
17
17
years of professional experience
Work History
Compliance Risk Analyst
TJX
Marlborough, USA
09.2021 - 10.2025
- Work on projects related to compliance with US state, federal, or local product laws that impact product safety and records management.
- Regularly collaborate with associates in various departments throughout the company to promote the goals of product compliance initiatives.
- Support drafting and maintaining guidance documents and standard operating procedures for the Consumer product supply chain.
- Review and validate product test reports, certificate of compliance, and labels to ensure merchandise conforms to US regulations and requirements.
- Support with training supply chain on product safety and US product regulations.
- Stay current on US product regulations (CPSC, FTC, EPA, USDA, etc.) and guide standard methodologies and trends on how they will impact the company's compliance program.
- Work with the supply chain to respond to incidents and help specific groups remediate findings in product safety assessments as needed.
- Ensure that compliance issues are appropriately elevated.
- Utilized a variety of databases and resources to conduct research and gather evidence.
- Documented the business requirements and provided 3 solutions in SAP.
- Performed comprehensive data reviews on customer sales data to identify discrepancies.
Compliance Manager
Extreme Bolt & Fastener
Waltham, USA
06.2018 - 08.2021
- Reviewed documents, files, protocols, test scripts, summary reports, and other records to assess compliance and potential risk.
- Ability to coach across different departments within the subject matter of investigations, CAPAs, general risk assessments, and validation.
- Evaluated customer complaints, processes, and all other aspects of operations to assess compliance and helped implement ISO certificates.
- Coordinated with cross-functional teams to integrate SAP modules, resulting in 20% reduction in data redundancy.
- Check our SOPs periodically to ensure that all information remains current.
- Write corrective actions to address the problem and preventive actions to avoid future recurrence.
- Make decisions independently.
- Acquainted with quality management cycle (i.e, PDCA) and Corrective Action/Prevention Action (CAPA) processes.
- Manage interface with Quality Compliance audit team to support audit, due diligence, and inspection readiness plans.
- Lead and direct all quality assurance activities for company.
- Oversee procedures for medical coding, internal data validation audit, clinical form development, data and outcomes management for all contract programs.
Quality Assurance
Integra Life Science
Boston, USA
07.2008 - 04.2018
- Identified development issues using various tools and testing techniques.
- Visual inspection and assuring materials comply with policies.
- Documented testing procedures for developers and future testing use.
- Raw material assays in a GMP manufacturing environment.
- Good understanding of post-market surveillance and following GMP/SOP/SAP/CAPA/Investigations requirements.
- Review complaints and make complaint decisions.
- Draft medical device reports in the allocated time frame.
- Collaborate with employees to collect dates and investigate the root cause of the identified complaints.
- First article.
Education
Biochemical Science -
MassBay
Wellesly, Mass06.2008
Skills
- Management/Team Lead
- Quality control/Quality Assurance
- Compliance documentation
- Document reviews
- Internal Audit
- System development
- Information gathering
- Quality Management Processes
- Vendor/Supplier Performance Management
- Analytical thinking
- Document Control Program
- ISO 13485
- ISO 9001
- AS9100
- Micrometer
- Calipers
- Investigations
- Read and interpret blueprints
- 21CFR
- First article
- SAP
- SOPs
- CAPA
- Good Manufacture Practice (GMP)
- Good Laboratory Practice
- Data Review
- QA Analytical
- Root Cause Analysis
- Deviation handling
Languages
- English
- Portuguese
- Spanish
Timeline
Compliance Risk Analyst
TJX
09.2021 - 10.2025
Compliance Manager
Extreme Bolt & Fastener
06.2018 - 08.2021
Quality Assurance
Integra Life Science
07.2008 - 04.2018
Biochemical Science -
MassBay