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 / Allergan 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).

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

Contact this candidate