MIKE GARCÍA

I perform visual and manual inspections of POTS units, adhering to Abbott's established quality and safety standards and FDA requirements.

I verify the integrity, functionality, and dimensional compliance of each unit, ensuring early defect detection and minimizing scrap on the production line.

I operate inspection equipment and tools in accordance with SOPs, GMP, and internal protocols for the medical device area.

I accurately record critical data in Electronic Manufacturing Systems (MES), maintaining complete process traceability.

I collaborate with trainers, supervisors, and the quality team to resolve deviations and support continuous improvements in efficiency and performance.

I support line clearance, inventory control, and strict adherence to safety practices.

• Supervised and coordinated the production of organic and non-organic products, ensuring compliance with GMP, HACCP, and ISO 9001.
• Led production teams to achieve quality, safety, and productivity goals.
• Managed resources, raw materials, and equipment to ensure efficient processes.
• Implemented improvements in quality control procedures and documentation.
• Ensured compliance with standards for major clients such as Walmart and amazon.

• Lead and motivate the team to meet production goals.
• Supervise the manufacturing process, ensuring that recipes, cooking times, and established procedures are followed correctly.
• Verify that products meet quality standards before packaging and distribution.
• Coordinate with other departments, such as maintenance and quality control, to resolve operational issues.
• Ensure compliance with safety and hygiene standards in the workplace.
• Train staff in good manufacturing practices and process optimization.
• Report on team performance and propose improvements to increase production efficiency.

• Operated IMA Capsule machine and Tablet machine koresch.
• Conducted major and minor cleaning.
• Worked in liquid and cream packaging area.
• Weighed products for blending.
• Operated Nuspark VRC 60 Machine, IMA Active zanasi 40E, and IMA Precisa 150.

• Processed manufactured products in accordance with manufacturing batch records.

• Performed machine changeover, cleaning, and setup as per requirement for next product.
• Maintained compliance at all times with related SOPs and GMPs in the manufacturing process.
• Dismantled, cleaned, sanitized, and assembled processing equipment and clean rooms in accordance with written SOPs and established GMPs.
• Completed manufacturing documents with accuracy and completeness.
• Operated compression machines with high speed, medium speed, and low speed.
• Operated machines such as high speed Eco Press 51 punches double outlet, high speed ZP400 51 punches double outlet, medium speed Stokes 20 punches, low speed Natoli 20 punch, Fitz Mill Compactor, pre-coating, and Liquid Capsule and banding Qualicaps S-100 machine.

• Monitored the manufactured product and ensured it corresponded with the SOP documents and other specifications.
• Conducted inspections on all machinery handling to provide a safe environment for the equipment and products.
• Maintained the ISO standards of the products and ensured proper handling of the inspection tools.
• Administered inspections in accordance with the Quality and certification programs to assure it meets all qualifying requirements.
• Inspected the products for optimal quality and prepared appropriate reports to manage the quality levels of the products.
• Monitored the equipment used and the procedures followed in the inspection process.
• Designed new and effective ways to improve the quality of the product while reducing the downturn.
• Participated in various meetings and discussions relating to quality issues.

• Operated tablet filling machine, labeling machine, and capsule filling machine.
• Conducted cleaning and sanitization of equipment and workplace as per SOPs.
• Documented activities into packaging order and equipment log.
• Demonstrated ability to operate a variety of mechanical production equipment.
• Loaded and lifted heavy materials.
• Read schematics and digital measuring equipment.
• Assembled and installed various components on the assembly line.
• Examined products to ensure conformance to quality standards.
• Staged, prepared, lifted, and loaded raw materials.
• Monitored and adjusted gauges, valves, and switches.
• Operated computerized and manual equipment for production processes.
• Completed appropriate paperwork associated with production work.
• Trained new hires.

• Processed manufactured products in accordance with manufacturing batch records.
• Operated various manufacturing equipment in Compounding.
• Performed machine changeover, cleaning, and setup as per requirement for next product.
• Maintained compliance at all times with related SOPs and GMPs in the manufacturing process.
• Dismantled, cleaned, sanitized, and assembled processing equipment and clean rooms in accordance with written SOPs and established GMPs.
• Completed manufacturing documents with accuracy and completeness.
• Performed duties through the proper, safe use of equipment, according to Health & Safety procedures and Equipment Manuals.
• Operated compression machines with kikosuy and Elizabeth-Hata.