1. Elizabeth Jiménez
Ft. Lauderdale, FL (954) 296-0461
elizjmnz24@gmail.com
Linkedin.com/in/elizabeth-jimenez
Quality Assurance / Compliance
Skilled professional in the Manufacturing and Quality Assurance of Pharmaceutical products. Extensive
experience in the Quality and Compliance field. Knowledge of Current Good Manufacturing Practices
(cGMP), Food and Drug Administration (FDA) and other regulatory policies. Experience in internal auditing
and performance evaluations. Pharmaceutical principles, practices and their applications, including safety
rules and regulations. Areas of expertise include:
• Annual Product review (APR) • Product Quality Complaints • QC/ Water Testing
• Corrective/Preventive Actions • Product Validation • Basic Microbiology Testing
• Trend Analysis on Deviations • Liquid Products Formulations • Sterility/Sanitation Practices
• Customer Complaints • Batch Records Review and Audit • Food Manufacturing
• JDEdward Expertise • Bilingual (English / Spanish) • FDA Regulations
Professional Experience
Teva / Allegan Pharmaceuticals, Sunrise, FL
QA Engineer 2008-8/2016
Prepared Annual Product Reviews inclusive of Statistical Process Control (SPC) analysis; Trend Analysis of deviations,
complaint investigations and associated corrective actions as well as development and execution of continuous improvement
projects.
• Reviewed and analyzed all information / summaries contained in the APR to ensure compliance with FDA
regulations.
• Coordinated investigations and wrote final complaints investigation report.
• Performed trending of product quality complaint data to allow early detection and evaluation of potential trends.
• Provide cross-functional support to other departments.
Actavis Pharmaceuticals, Davie, FL
QA Material Disposition Auditor 2004-2008
Reviewed documentation associated with raw materials, product intermediate and finished product;
prepared documentation for final product disposition.
• Audit Quality Control data, vendor’s certificates, and other relative documentation of products and materials.
• Perform Batch Records audit and disposition for finished product and intermediates.
• Review Stability data documents.
• Audits documentation and release / reject incoming materials (raw material, packaging
components and labeling).

2. Elizabeth Jiménez
Ft. Lauderdale, FL (954) 296-0461
elizjmnz24@gmail.com
Linkedin.com/in/elizabeth-jimenez
Watson Pharmaceuticals, Davie, FL
Document Control Technician 2001-2004
Issued of commercial, experimental and validation Batch Records as well as assigned Expiration Date to finished products.
Typed and reviewed Master Batch and Packaging Records. Issuance of Master and One-Time Use Recipes.
• Maintain files for all current and obsolete Batch Records, Packaging Records and manufacturing recipes.
• Filed of Laboratory Data, Raw Materials, Master and executed Protocols, Reports, Master and executed Batch
Records and Packaging Records, Recipes, Planned Deviations and Product Code Request forms.
• Responsible for compile, organize, review and retrieval of documents.
Additional Relevant Experience
Easton, Inc.
Development Specialist
Developed master formulation and specifications for company owned products, including raw materials and packaging
components. Validated and improved methods and processes of raw material and manufacturing products. Assure
compliance with current procedures and specifications through development of sampling plans and analytical testing
methods. Internal audits for the manufacturing area hygiene program. Responsible for the manufacturing and quality control
personnel training programs. Develop Master BOM specifications and SOP’s. Supervision and support of the Blow Molding
manufacturing operation.
Education
Bachelors of Science, Biology, Inter-America University, Puerto Rico
Completed 36 credits towards MBA, University of Phoenix, Puerto Rico
Knowledge and Skills
Microsoft office, Lotus Notes, Excel, JDEdward, Trackwise
Fully Bilingual (English/Spanish)
Supervisory experience
Professional Affiliations
OpEx Pharmacy Operational Improvements –Actavis 2015
ASQ