Review the SOP’s and formsCompleted the TOC and Conductivity, Filtration, Gram, Series Dilution, Gowning and Laminar Flow Hood test qualifications.Performed and review microbial testing following approved methodology to assure that the company products are in the compliance with approved specifications.Participate actively in the performance qualification of the sterilizer in the execution of the microbial growth promotion, biological indicator incubation and culture media sterility… Show more Review the SOP’s and formsCompleted the TOC and Conductivity, Filtration, Gram, Series Dilution, Gowning and Laminar Flow Hood test qualifications.Performed and review microbial testing following approved methodology to assure that the company products are in the compliance with approved specifications.Participate actively in the performance qualification of the sterilizer in the execution of the microbial growth promotion, biological indicator incubation and culture media sterility check.Provide support to the microbiology supervisor during Corporate and Clients AuditsPerform Microbial Identification by BIOLOG and DNA Microsec.Perform the laboratory investigation.Perform Microbial Limit Testing of Raw materials, Finished Products.Culture media preparation.Microbiology Filtration Test (Water Samples)Manage Microbiology Environmental Samples (Air and Equipment samples)Performed Water Chemical test (Characteristic, Total Organic Carbon, Conductivity test).Perform GAP analysis to SOP and Guidelines Show less

Performed the Atypical Investigation and observations for Manufacturing Capsules Operations.Audit the manufacturing Capsules Operations on weekly basis.Performed Complaints Investigations.Review the Cleaning SOP’s and forms for QMS Project.Review the SOP’s and formsPerformed MPD Stamping and Special Instructions for MCO operations.Gave Supported an other areas in Microbiology Issues:Audit External Microbiology Laboratory (Quality Operations)Reviewed technical… Show more Performed the Atypical Investigation and observations for Manufacturing Capsules Operations.Audit the manufacturing Capsules Operations on weekly basis.Performed Complaints Investigations.Review the Cleaning SOP’s and forms for QMS Project.Review the SOP’s and formsPerformed MPD Stamping and Special Instructions for MCO operations.Gave Supported an other areas in Microbiology Issues:Audit External Microbiology Laboratory (Quality Operations)Reviewed technical documentation for Technical Operations personnel.Train the pharmaceutical operators on corrective actions to atypical investigations and the atypical and observations reports.Policies and guidelines evaluations. Show less

Performed the Atypical Investigation and observations for Manufacturing Capsules Operations.Audit the manufacturing Capsules Operations on weekly basis.Performed Complaints Investigations.Review the Cleaning SOP’s and forms for QMS Project.Review the SOP’s and formsPerformed MPD Stamping and Special Instructions for MCO operations.Gave Supported an other areas in Microbiology Issues:Audit External Microbiology Laboratory (Quality Operations)Reviewed technical… Show more Performed the Atypical Investigation and observations for Manufacturing Capsules Operations.Audit the manufacturing Capsules Operations on weekly basis.Performed Complaints Investigations.Review the Cleaning SOP’s and forms for QMS Project.Review the SOP’s and formsPerformed MPD Stamping and Special Instructions for MCO operations.Gave Supported an other areas in Microbiology Issues:Audit External Microbiology Laboratory (Quality Operations)Reviewed technical documentation for Technical Operations personnel.Train the pharmaceutical operators on corrective actions to atypical investigations and the atypical and observations reports.Policies and guidelines evaluations. Show less

Performed and review microbial testing following approved methodology to assure that the company products are in the compliance with approved specifications.Participate in the method validations and laboratory investigations.Train Laboratory technicians on test method and instrument operation.Perform troubleshooting, maintenance, performance monitoring and backup on microbial biochemical identification system (BIOLOG).Developed Standard Operation Procedure (SOP) and worksheet… Show more Performed and review microbial testing following approved methodology to assure that the company products are in the compliance with approved specifications.Participate in the method validations and laboratory investigations.Train Laboratory technicians on test method and instrument operation.Perform troubleshooting, maintenance, performance monitoring and backup on microbial biochemical identification system (BIOLOG).Developed Standard Operation Procedure (SOP) and worksheet for operation and maintenance of laboratory instruments.Develop SOP for the use of Laboratory Information Management System (LIMS).Gave supported to establish and implement LIMS System for the Raw Material Laboratory.Develop and maintenance of system dictionaries such as: Test, Calculation, Specifications, Event Protocol, Report procedures, Prompt code, and performance monitoring.Participated in the implementation of System Life Cycle Project in the microbiology laboratory to assure that all microbial laboratory equipment is in compliance with year 2000.Developed the Start-up of microbiology Laboratory.Participate in the method validations and laboratory investigations. Developed microbiology procedures and coordinated the microbial sampling in Arecibo site production area.Participated in the potable water system and cleaning validation.Provided support to quality control auditors in the revision of manufacturing and packaging documentations.Performed internal and external laboratory audit according to the regulatory procedures.Performed the purchase requisitions and keep laboratory supplies inventory.Coordinated the task distributions to the laboratory technicians and microbiology analyst Show less