Jessenia Alvarado

* Standardization and used of simple analytical instrumentation ( ph meter, osmometer, torque meter, balance ) and measurement devices ( ruler, micrometer, go/no go gauges)

* Material/ Product Sampling per a pre- defined schedule

* Evaluation of the material/products for conformance to visual and functional specifications

* Conduct AQL testing on finished product per sampling plan

* Per AQL sampling plans, prepare samples for delivery to the Chemistry and Microbiology labs, and customers by inspecting, labeling, and documenting the samples

* Complete, accurate, detailed and legible documentation of sampling completion and results obtained in accordance with cGMP

* Communications with the supervisor, and other departments when problems are identified, or assistance is required

* Coordination of activities with peers in the dynamic manufacturing environment

* Maintain effectiveness of the Quality System components relevant to this position

* Line Clearance

* Other duties as assigned

* Visually inspect bottles for legible lot numbers and expiration date; inspect, for trim, leaks, and others defects; trim excess flash off product units manually as required

* Visually inspect pouches and other printed components for legible lot numbers and expiration date and other defects

* Load foil, literature, cartons, and other packaging components onto equipment as required

* Proper use of e such as safety sealers, box makers, shrink machines, inkjet printers, laser scanners, label printers, inserts counters and inner carton Stream feeders, conveyors, seal bags on heat sealing machine, etc.

* Place units in plastic bags or inner cartons with inserts and/or adapters, as required; check sealed bags or shrink wrapped items for complete and proper packaging of products; place packed items in cartons, seal and apply shipper label stack carton on skid

* Monitor machinery for jam-ups or the malfunctions, informing appropriate level of supervision, turning machine off when necessary

* Review Clients Orders, for accuracy, so that clients receive what they ordered online

* Audits production lines process from the start to finish to guarantee quality

* Verify and document the warehouse temperature

* Verify the package has everything regulated by the correscorresponding agencies

* Audit production lines

* Checking the first piece of production, and continue to check parts ( in-lines ) until final process of wave springs & retaining ring

* Take the measurements of the dimensions with caliper, micrometer, scale, Optic ( angles, distances, waves, height, width ), hardness tester, go/no gauges, plugs, manual tester, automatic tester, template, print ( draw )

*Approve or reject the product according to the results obtained from the dimensions taken in consideration the specifications of the customers and the regulatory agencies

* Rework

* Line clearance

* Customer Complaint

• Evaluated and defined internal and customer needs, implementing processes to address requirements.
• Organized project implementation resources and leveraged expertise to assist organizational rollout.
• Cultivated project timelines, documentation, processes and updates to develop and manage tactical plans.
• Audit in the process of the validations of the new manufacturing machines.
• Give the training to the associates so they can do good execution of the equipment with high technology.
• Make the reports of the test result; daily, weekly, monthly, annual general report to make the comparison of how improve the quality of the product.
• In the last two years I belonged to the Innovation Project Team, in which I was given the oppo to be in charge of Quality Control Team, and giving support to the engineer and technicians in the validations process.

• Inspected the sterilized product according to the specifications and quality procedures established.
• Run tests to verified the quality of the final product in accordance with existing procedures and using appropriate test equipment.
• Check the documentation of the final product and ensure it meets the requirements according to established procedures.
• Run the disposal of the product using the systems established for approval.
• Take the provision ( approve or reject ) "Parametric Release" sterilization cycles.
• Take provision ( approve or reject ) the " inserts" to be used in the manufacture of contact lenses.
• Run and verify the calibration of measuring necessary for the tasks such as PH meters.
• Documenting audit results of the dimensional in the Infinity QS system.
• Reports samples taken during the inspection of the product in the BPCS system.
• Conduct and/ or coordinate some works as parts of special projects and/ or temporary roles.
• Audit compliance procedures during the QA process and manufacturing.
• Organize and archive documentation lots and sterilizations cycles.
• Segregate and identify the product rejected Cage Quarantine
• Prepare and perform file documentation.
• Maintain control of the documents provided to the other department/areas.
• Provide supports in the search and/or file documents concerning FDA visits or audits.
• Provide information and/or reports to the " Process and Quality Improver's" documentation of non conforming lots.
• Evaluated components and final products against quality standards and manufacturing specifications.
• Reported repeated issues to supervisors and other departments, collaborating to identify issue roots and rectify problems.

• Audit the product from the beginning to the end of the process.
• Verify that the process meets the specification, and quality process.
• Take different dimensions as required by the product (power, base curve & diameter, visual, dry center thickness, wet center thickness, etc.).
• Verify the calibration date before using any equipment inside the clean room or in the laboratory.
• Take samples at the beginning of the process, during, and at the end of the lot.
• Document all audits in the QSI system.