Experience

Weil Group, Inc.

• Outsourcing/Offshoring
• 1 - 100 Employee

• Quality Assurance Specialist

  • Oct 2016 - Present

  Provide QA support to biotechnological manufacturing process. Review of manufacturing documentation, Investigations, SOPs. Provide QA support to biotechnological manufacturing process. Review of manufacturing documentation, Investigations, SOPs.



TAPI - Teva Active Pharmaceutical Ingredients

• Guayama, Puerto Rico

• QC Laboratory Manager

  • Dec 2015 - Oct 2016

  Leads API’s QC Laboratory, for Raw Material, Inprocess, Product Release and Stability according to cGMP requirements. Leads API’s QC Laboratory, for Raw Material, Inprocess, Product Release and Stability according to cGMP requirements.



PRISM-A Consultants Inc

• Cornelia, Georgia, Estados Unidos

• Methods Validation Lead

  • Oct 2015 - Dec 2015

  Leads Method Validation Process. Protocol creation, train and monitors validation process, Report generation. Leads Method Validation Process. Protocol creation, train and monitors validation process, Report generation.



Pro Assets Inc.

• • Oct 2014 - Oct 2015

  Performs Laboratory Investigations finding root cause and establishing CAPA and monitor effectiveness.

• • Oct 2014 - Oct 2015



Kelly

• United States
• Staffing and Recruiting
• 700 & Above Employee

• Quality Assurance Specialyst (PQA)

  • May 2012 - Oct 2014

  * Provide technical guidance and compliance assessments to the Manufacturing group. Detailed technical understanding of bioprocessing unit operations. * Identify and initiate NC on the manufacturing process * Review and approve NC (Non Conformance), MP (Manufacturing Procedures), SOP, Change Control and Validation Protocols * Representing the department/organization on various teams * Reviewing Batch records * Following through on group/departmental action items. * Provide technical guidance and compliance assessments to the Manufacturing group. Detailed technical understanding of bioprocessing unit operations. * Identify and initiate NC on the manufacturing process * Review and approve NC (Non Conformance), MP (Manufacturing Procedures), SOP, Change Control and Validation Protocols * Representing the department/organization on various teams * Reviewing Batch records * Following through on group/departmental action items.



Eli Lilly and Company

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Chemist

  • Sep 2010 - Mar 2012

  * Coordinate laboratory schedule according to manufacturing and disposition’s requirements. * Train analyst following GLP. * Directly supervise analyst daily work. * Identify analytical issues, investigate and establish corrective and preventive actions. * Improvement analytical methods and process. * Coordinate laboratory schedule according to manufacturing and disposition’s requirements. * Train analyst following GLP. * Directly supervise analyst daily work. * Identify analytical issues, investigate and establish corrective and preventive actions. * Improvement analytical methods and process.



Ivax Pharmaceuticals

• Stability / Analytical Services Manager

  • Jun 2001 - Mar 2007

  * Provides guidance and oversight in maintaining the laboratory according to company policies and procedures, and cGMP guidelines and regulations * Directly supervises the subordinates responsible for the technical and administrative guidance of chemist and laboratory staff or, in lieu of said supervision, provides direct supervision to laboratory personnel. * Provides expertise to subordinates in the proper performance of laboratory procedures * Provides general management of personnel to assure that subordinates follow and comply with company policies, procedures, cGMP’s, OSHA, DEA company guidelines, codes and/or regulations. * Assures schedules of the laboratory workload satisfy business requirements * Oversees all laboratory-training programs * Evaluates data and issued reports with interpretations and recommendations * Follow-up and report on quality improvement systems * Assist manufacturing management in identifying potential quality problems. Develop systems for the prevention of problems * Interacts with internal/external auditors to assure quality systems are understood and documentation is clearly understood and available in order to minimize quality operations/companies regulatory exposure Show less