Emilly Nuñez Arroyo

• Management in receiving water and environmental samples, completing incubation process, reporting reading and testing of microbiological samples.

• Perform and monitoring microbiological testing of water samples in accordance with internal procedures or compendia requirements.

• Documentation and interpretation of results according to procedures.

• Data recompilation of microbiological samples when performing microbiological analysis.

• Reporting microbiological data on computerized and manual systems.

• Performing data verification and approval of Laboratory Documentation.

• GMP Data management in GLIMS (Electronic system), e-log system and logbooks.

• Participate on investigations collecting data, detecting and reporting microbiological failures.

• Full Management of SOP’s, GMP Documentation and FORMS.

• Record, analyze and interpret data.

• Perform routine and non-routine laboratory procedures, including sampling, protocols, equipment validations and analysis for both compendial and non-compendial methods.

• Conduct or support activities such as sample testing, standards and reagent preparation, environmental monitoring, sample management, and equipment maintenance.

• Ensure accurate, complete, and timely documentation of laboratory work, and participate in document revisions as needed.

• Review, analyze, and communicate test results; may participate in investigations, audits, or approve laboratory results as applicable.

• Complete all work in compliance with established procedures and scientific/technical standards.

• Knowledge of ID testing and management.

• Knowledge in the management of laboratory equipment such as: monitoring and sampling equipment, incubators, testing equipment.

• Support routine GMP documentation review activities related to Electronic batch records, SOP’s, Logbooks, Non-conformance, Process Development results, work orders, batch production reports and validation protocols.

• Mentor and coach cross functional team members in order to establish a quality culture for routine operations.

• Manage systems such as BTRS, SAP, Trackwise, EBR(werum), Maximo and LIMS.

• Participate in internal plant audits.

• Compliance review of batch record elements and identification of discrepancies.

• Perform and monitored Sampling of product, AQL and final packaging inspections, monitored manufacturing inspection lines for adherence to the Quality System Regulation and SOP’s.

• Monitor and audit routine manufacturing process.

• GMP knowledge with ability to interpret and apply in routine cases. • Performed Oversight of Inspection and packaging operations

• Demonstrated skills in problem solving and providing solutions, participate in investigations performing work of associate QA (Quality Assurance).

• Ability in Basic understanding of analytical methods used in support of facility process monitoring.

• Participate in root cause investigations for complex and significant non-conformance, leveraging various root cause analysis tools.

• Ownership of the Quality Process documentation such as procedures, training material, forms and templates.

• Perform diversified duties under immediate supervision concerning the visual of In Process Product according to sampling plans using the required testing equipment

• Analyze and dispose of Raw Materials, work in process, finished product, stability samples.

• Performed data entry in LIMS and SAP.

• Evaluates and proposed methods to improve laboratory process.

• Coordinates and Plans Activities for laboratory Areas.

• Performed sampling and microbiological analysis, ensure that they are within established parameters.

• Assists in training new personnel in the laboratory.

• Coordinates and participates in validations and qualifications of the laboratory and manufacturing area equipment/processes.

• Assists the supervisor in the development and revision of operational procedures.

• Performs safety/environmental audits in the microbiology laboratory.

• Reviews and approves the documentation required to ensure compliance with company procedures and regulatory agencies.

• Meets the goals established for the department and promotes team work to achieve such.

• Manages, Disposes and Stores the Biohazard and Non-Biohazard waste Generated.

• Support routine GMP documentation review activities related to Electronic batch records, SOP’s, Logbooks, Non-conformance, Process Development results, work orders, batch production reports and validation protocols.

• Mentor and coach cross functional team members in order to establish a quality culture for routine operations.

• Manage systems such as BTRS, SAP, Trackwise, EBR(werum), Maximo and LIMS.

• Participate in internal plant audits.

• Compliance review of batch record elements and identification of discrepancies.

• Perform and monitored Sampling of product, AQL and final packaging inspections, monitored manufacturing inspection lines for adherence to the Quality System Regulation and SOP’s.

• Monitor and audit routine manufacturing process.

• GMP knowledge with ability to interpret and apply in routine cases. • Performed Oversight of Inspection and packaging operations

• Demonstrated skills in problem solving and providing solutions, participate in investigations performing work of associate QA (Quality Assurance).

• Ability in Basic understanding of analytical methods used in support of facility process monitoring.

• Participate in root cause investigations for complex and significant non-conformance, leveraging various root cause analysis tools.

• Ownership of the Quality Process documentation such as procedures, training material, forms and templates.

• Perform diversified duties under immediate supervision concerning the visual of In Process Product according to sampling plans using the required testing equipment.

• Directly Experience in samplings like: Purified water, Tap water, Environmental Air, Compressed Air, Product Equipment surface sampling.

• Completely experience handling testing for Raw Materials, Finished Product, Stability samples, validation samples.

• Perform routine and non-routine laboratory procedures

• Media management in all its facets: Receiving media, making sterility test, Growth Promotion test, Inhibitory test, Inoculums verification test.

• Directly management of different types of microorganism, pellets, dilutions, positive controls.

• Perform or review all data related to laboratory testings and equipments.

• Prepare complete, accurate, concise laboratory documentation

• Data entry, review, analysis and communication of results

• Management of laboratory equipments: Incubators, Biological safety cabinets, Balances, Chart recorders.

• Perform general lab housekeeping

• Maintain/operate specialized equipment

• Comply with safety guidelines, cGMPs and other applicable regulatory requirements

• Experience participated in lab investigations and approving lab results

• Ability to relate day-to-day work to business priorities

• Collects required documentation/raw data; verifies conformance of documents

• Experience Applying based research, analytical skills to factual information

• Direct participation on 6S.

• Completes work in accordance with established procedures and practices following SOP’s.

• Directly management of Environmental flora, purification, isolation, Gram stain and shipping of microbial identification test.

• Experience handling Tablets, capsules and raw material weighing.

• Management of testing results and controlled documentation before and after the incubation period of each sample handling.

• Ability to work in team to support achievement of lab procedures

Environmental Monitoring Laboratory:

• Support receiving, handling and reporting environmental samples monitoring in QC Microbiology labs. (Environmental Monitoring)

• Provided results through LMES, audit laboratory documentation.

• Support product and laboratory validations.

• Management of equipment related to monitoring program.

• Monitoring hoods and manufacturing areas. Microbiology Sample

Management Associate:

• Interact with different departments and Amgen sites in order to solve various issues and maintain effective communication about samples involving validation processes, protocols and urgent sample testing.

• Daily tasks involving gowning procedures into manufacturing areas and laminar flow hoods in the microbiology laboratories, implementation of plan improvements to routine functions in order to facilitate solutions to complex problems (visual and analytical).

• Support in projects that involved attention to details, teamwork, 6S, GMP documentation and lean transformation.

• Support in handling samples that are shipped and traded internationally as other Amgen sites, Europe and contract labs.

• Support to ensure the quality of each sample that will be tested and going to be shipped.

• Aliquot samples such as Bio burden, Biochemistry samples and Reserve samples using excellent aseptic techniques. Commercial lots sampling.

• Expertise working with SAP, LIMS, and BTRS system with different kind of responsibilities.

• Management and organizing reserve inventory in order to facilitate its search in case of activation, keep track of the samples and experience with customer service skills which includes handling of raw materials, in process and drug product QC samples to in site and out site laboratories.

• Experience working with basic laboratory equipment as calibrated equipment, chart recorder, laminar flow hoods, pipettes, microscope.

Stability Laboratory:

• Knowledge of products and FDA regulations that are related to stability program

• Management of all type of samples and product in stability area like products aliquots and new time device studies.

• Stability aliquots, SATM test

• Documentation and Data evaluation of all stability studies.

• Coordinate study initiations with Stability Product Representatives. • Management all type of samples at many conditions and factors to supporting stability studies