Pharmaceutical Chemist graduated from the University of Cartagena, Colombia, Over 22 years of experience in Quality Control with the Pharmaceutical, Food and Nutraceutical Manufacturing fields, with knowledge in chemical analysis of raw materials, in-process products, finish products and packing materials.
Experienced in the handling of analytic instrumentation including HPLC, HPTLC, ICPE, ICP-MS, TruSpec N, FTIR and UV/Vis Spectrophotometer, creating and reviewing documentation of Batch Records and SOP's, and with proprietary software applications including Microsoft Office and SAP. Able to execute daily, weekly and monthly inventories.
MS Office Applications: Word, Excel, Power Point, and Access.SAP Software HACCP certification and manufacturing Control Plan. |
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Served as the Chemical Lab Lead for 3 years.
- Manage personnel daily task and schedules.
- Review and approve testing documentation of analysis (notebook write-ups, worksheets, etc).
- Provide full training on methods and general laboratory practices to incoming Chemists and Technicians.
- Provide the annual evaluations of each to the QC Manager.
- Manage Wet Lab Supplies and respective budget.
- Manage Equipment issues Development of personnel to meet Lab tasks per business requirements.
- Review Finished Product Specification Sheets for final approval.
- Conduct and document chemistry laboratory investigations.
- Create and revise Standard Operating Procedures.
- Operated Analytical Instrumentation including HPLC, HPTLC, ICP-E, ICP-MS, TruSpec N (for Protein analysis), FTIR, Dissolution tester and Automatic titration.
- Analyzed raw materials, in-process products and finished products.
- Operated Analytical Instrumentation including HPLC and Dissolution Tester.
- Responsible for the specification compliance of existing finished products.
- Responsible for quality assurance and quality systems compliance and documentation, reporting to the Quality Assurance Management.
- Development of new Analytical Methods.
- Responsible for the compliance and documentation of all quality assurance programs and systems, reporting to the Senior Quality Technician.
- Led effective improvements of specific quality assurance program such as achieving 100% accuracy on first time quality reporting.
- Refined the procedures for the calibration of the processing equipment used for the generation, measurement, or assessment of data.
- Identified opportunities and implemented improvements to the chemical control program, streamlining the approval and purchasing process.
- Managed the update of raw material labeling and testing procedures.
- Accountable for the training of all personnel in the documentation and enforcement of the Good Manufacturing Practices of the facility.
- Supervised all manufacturing controls, process and systems.
- Audited all quality Assurance policies and programs.
- Responsible for the daily review of all production records for Positive Release of products.
- Updated HACCP manual an HACCP systems and definitions to meet FDA guidelines.
- Responsible for the accuracy of a trace recall system capable of tracing and locating 100% of raw material to finished goods within the supply chain within thirty minutes.
- Developed standardized report formats for Quality Assurance.
- Responsible for the revision, updating, and regulatory compliance of Standard Operating Procedures and plant polices.
- Controlled and managed the Environmental Monitoring Program testing to ensure regulatory compliance.
- Responsible for all quality assurance programs and Quality Systems compliance and documentation, reporting to the Quality Assurance Manager.
- Implement Good Laboratory Practices standards as defined on the FDA Code of Federal Regulations, Title 21.
- Developed and implemented Standard Operating Procedures.
- Developed standards for the collection of data and validated records, insuring effective batch control for product release and traceability.
- Accountable for the accuracy and completeness of statistical data analysis performed by lab technicians.
- Organized and prepared documentation for regulatory agencies audits.
- Evaluated processes performance, quality statistic reporting, and data processing.
- Reviewed/analyzed and approved certificate of analysis emitted by the analysts.
- Responsible for the professional development and supervision of 9 pharmaceutical chemist analysts.
- Coached and trained technicians on the use of lab equipment and their duties.
Excellent attention to detail. Strong analytical skills.
Ability to work with a variety of colleagues within Product Development and from other departments as well as different levels of Management. Skilled at multitasking.
Ability to work under pressure to meet deadlines.
Strong critical thinking, communication, and problem solving skills. Ability to work on problems of diverse scope where analysis of a situation or data requires evaluation of various factors.
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School Attended
- University of Cartagena
Job Titles Held:
- Chemist II
- Chemist
- Quality Technician
- Quality Lab Supervisor
Degrees
- Bachelor of Science
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