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/product for conformance to visual ans 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 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 required.

Coordinated 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.

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

Audits production lines process from the beginning to the end of the process following customer and quality specifications.

Verify and document the warehouse temperature.

Verify the package has everything regulated by the corresponding agencies.

Enhanced product quality by conducting thorough inspections and identifying areas for improvement.

Reduced defects in production by implementing meticulous inspection processes and protocols.

Collaborated with manufacturing team to ensure consistent quality standards across all products.

Developed and maintained comprehensive documentation for quality control procedures, increasing efficiency and transparency.

Checking the first piece of production, and continue to check parts (in-lines) until final process of waves springs & retaining rings.

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

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

Rework

Line Clearance

Customer Complaint

Evaluated and defined internal and customer needs, implementing process to address requirements.

Organized project implementation resources and leveraged expertise to assist organizational rollout.

Cultivated project timeless, documentation, processes and updates and manage tactical plans.

Audit the process of the validations of the new manufacturing machines.

Give the training to th associates so they can do good execution of the equipment with high technology.

Make the reports of the tests results; daily, monthly, annual general report to make the comparison of how improve the quality of the product.

In the last to years I belonged to the Innovation Project Team, in which they gave me the opportunity 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 test 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 meet the requirements according to established procedures.

Run the disposal of the product using the system 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 audits results of the dimensional in the infinity QS System.

Reports samples taken during the inspection of the products in the BPCS system.

Conduct and/ or coordinate some works as parts of special projects and/ or temporary roles.

Audits compliance procedures during the QA process and manufacturing.

Organize and archive documentation lots and stabilizations cycles.

Segregate and identify the product in the Quarantine Cage.

Prepare and perform file documentation.

Maintain control of the documents provided to the others department/areas.

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 reported 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 as the beginning of the process, during, and at the end of the lot.

Document all audits in the QSI System.