Emily Rodriguez
Auburndale,FL
Summary
Quality Assurance professional with extensive experience in reviewing GMP documents and manufacturing batch records to ensure compliance with federal regulations. Proven track record of delivering accurate work through meticulous attention to detail. Skilled in verifying documentation to prevent errors and reduce rework.
Overview
8
8
years of professional experience
1
1
Certification
Work History
Quality Assurance Document Specialist
American Laboratories, LLC
01.2021 - Current
- Utilize good Documentation practice GDP to ensure documents created or review are complete, accurate , legible, contemporaneous, original and attributable (ALCOA).
- Utilization of Master Control electronic document system and Share Point.
- Release production lots based on product specifications.
- Provide training to local employees and others in relevant areas.
- Assist with ALI audit team during regulatory audits.
- Conducted regular internal audits to identify non-conforming issues.
- Identified areas of improvement within the existing Quality Management System.
- Assist other departments with documentation, scanning, laminating, logbooks, letters of Guarantee uploading, batch record issuance etc.
- Monitored QA procedures for adherence by employees, notifying personnel of non-compliance issues.
- write and analyze written Standard Operating Procedure (SOPs) and submit procedural changes to meet Regulatory Requirements.
- Assist Management with Change Controls, CAPAs and open investigations.
- Tracking batch records for documentation errors.
Quality Assurance Receiving
American Laboratories, LLC
01.2019 - 01.2021
- Receiving incoming material
- Review receiving incoming material documentation
- Coordination sampling and testing
- Product and components releasing for production
- Labeling releasing, QA hold and Quarantine
- Provided technical support to production staff on matters related to Quality Assurance.
- Documented non-conformance issues, identified corrective action plans, tracked progress, and reported final resolution status for each issue.
- Monitored product trends and suggested changes.
Quality Assurance Shop Floor
American Laboratories, LLC
01.2018 - 01.2019
- Ensured that all products meet established company quality standards prior to release.
- Trained personnel on proper use of equipment and techniques used in Quality Assurance activities.
- Maintained accurate records of all Quality Control tests performed throughout the manufacturing process.
- Review Manufacturing batch records and identify documentation errors.
- Oversight Manufacturing process performance to be in compliance with regulatory.
- Maintain batch records scanned and archive.
Education
Associate of Science - Nursing
Center of Study Multidisciplinary
Humacao, PR 09-2013
Skills
- Team collaboration
- GMP document review
- Operational procedures
- Regulatory compliance
- Good documentation practices
- Master Control system management
- SharePoint proficiency
- Internal audits
- Problem assessment
- Effective communication
- Documentation archiving and scanning
- Reporting and documentation
- Relationship building
Certification
- Certified HACCP Principles for Meat and Poultry
- GMP Audits: Basic Tools and Techniques
- Proper Batch Record Review for Compliance and Effectiveness
- Time Management
Languages
Spanish
Native/ Bilingual
English
Professional
Timeline
Quality Assurance Document Specialist
American Laboratories, LLC
01.2021 - Current
Quality Assurance Receiving
American Laboratories, LLC
01.2019 - 01.2021
Quality Assurance Shop Floor
American Laboratories, LLC
01.2018 - 01.2019
Associate of Science - Nursing
Center of Study Multidisciplinary
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