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perla alonso

@perlaalonso

Quality Systems Specialist at Accriva Diagnostics managing SAP training compliance and supporting audits in medical device manufacturing.

United States
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At Accriva Diagnostics, I manage the Training Program, including SAP training administration, curriculum creation, assignments, and compliance tracking. I ensure training records meet FDA QSR, ISO 13485, GMP, and internal quality requirements.

I deliver new hire training and review change orders to assess training impact. I also conduct internal audits and provide backroom support for internal and external audits.

At Accriva Diagnostics, I collect and analyze Quality System KPI data, prepare Management Review quality metrics, and assist with CAPA documentation review and support activities.

Earlier, as a Quality Records Coordinator I, I reviewed Device History Records and approved product release through ERP systems. I also performed final product release testing using Hemochron Signature Elite, Avox, and VerifyNow devices.

Experience

Work history, roles, and key accomplishments

Education

Degrees, certifications, and relevant coursework

PA

PathWise

Investigations and CAPA Training, Quality Management

Completed Investigations and CAPA training through PathWise.

LS

Lean Six Sigma

Lean Six Sigma, Process Improvement

Completed Lean Six Sigma training.

JA

Japan Regulatory Affairs & Quality Assurance

Japan Regulatory Affairs & Quality Assurance, Regulatory Affairs

Completed training in Japan Regulatory Affairs and Quality Assurance.

AT

Advanced Internal Audit Process Training

Advanced Internal Audit Process Training, Quality Auditing

Completed advanced internal audit process training.

Tech stack

Software and tools used professionally

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