Experience

Om Mushroom Superfood

• United States
• Health, Wellness & Fitness
• 1 - 100 Employee

• QC Manager

  • Mar 2017 - Present

• QA/QC Associate

  • Feb 2016 - Mar 2017

  ♦ Perform pre-operational inspections on manufacturing areas, production lines, machinery and equipment.♦ Monitor work being produced to make sure it meets all specifications.♦ Operate, maintain and calibrate testing equipment and lab instruments.♦ Perform cleaning inspection, swabbing, sampling and another QC related duties.♦ Perform and file daily monitoring and verification of the production activities.♦ Assist line personnel in resolving job related issues.♦ Comply with cGMP documentation and regulations. Show less



Olli Salumeria

• United States
• Food and Beverage Manufacturing
• 1 - 100 Employee

• QA Associate

  • Dec 2015 - Feb 2016

  ♦ Perform pre-operational inspections on manufacturing areas, production lines, machinery and equipment. ♦ Create and distribute inspection reports communicating failures and non-conformances to QA and Production management. ♦ Operate, maintain and calibrate laboratory instruments. ♦ Perform pH and aW testing as required on in-process product for release. ♦ Perform and file daily monitoring QA checklist. ♦ Comply with cGMP documentation and regulations. ♦ Perform pre-operational inspections on manufacturing areas, production lines, machinery and equipment. ♦ Create and distribute inspection reports communicating failures and non-conformances to QA and Production management. ♦ Operate, maintain and calibrate laboratory instruments. ♦ Perform pH and aW testing as required on in-process product for release. ♦ Perform and file daily monitoring QA checklist. ♦ Comply with cGMP documentation and regulations.



MeriCal, Inc.

• Formulation Technician

  • Sep 2013 - Apr 2015

  ♦ Assist in formulation of new products or reformulation of existing products for a variety of solid dosage and delivery forms (tablets, capsules and powders).♦ Update, and keep accurate formulas and label claims for customer products.♦ Produce and maintain accurate records of all product development activities.♦ Assist purchasing in the specification and sourcing of excipients or active ingredients.♦ Prepare and review stability protocols for compliance per ICH guidelines.♦ Managing stability studies activities such as planning, sampling, scheduling, sending, tracking, monitoring, collecting, reviewing and reporting.♦ Reviewing all stability data, calculations and results on lab reports and COAs.♦ Analyzing and interpreting stability results to identify trends and create projections.♦ Evaluate, summarize and report the results of stability studies and formulation prototypes.KEY CONTRIBUTIONS:♦ Redesign, development and implementation of a new Stability Program improving protocols, scheduling, tracking, monitoring, data analyzing, reports and results presentation in an effective and systematic manner to ensure product stability compliance.♦ Creating and maintaining a monograph file system of Raw Material Specification to assist the purchasing department in the sourcing, QC department in the receiving and as a technical reference to other departments. Show less

• Laboratory Technician (Micro & Chem)

  • Oct 2011 - Sep 2013

  ♦ Perform microbiological and chemical testing on raw materials, in-process and finished products.♦ Preparation, sterilization and storage of culture media, reagents, buffers and standard solutions.♦ Inoculation, Incubation, storage, safety handle and disposal of biohazardous, infectious and corrosive waste.♦ Preparing and maintaining pure and stock cultures.♦ Perform aseptic transfer techniques, including Streak Plate, Pour Plate, Spread Plate, simple and differential (Gram) stains, bacterial and fungal identification, Serial Dilutions, Colony Count, Most-Probable-Number (MPN) and Membrane Filtration.♦ Perform microbial testing of raw materials and finished products: Bioburden (TVC, TYMC) and Pathogen Detection-Identification (coliforms, enterobacteriaceae, E. coli, Salmonella, Staphylococcus, and Pseudomonas).♦ Perform probiotic enumeration on finished products intended for this purpose.♦ Perform environmental monitoring: air, water and surfaces.♦ Operation, maintaining, monitoring and troubleshooting of standard laboratory equipment and instruments: balances, pH-meters, aw-meters, titrators, digestors, microscopes, micropipettes, incubators, fridges, autoclaves and stability chamber.♦ Performing bench chemistry testing such as pH, moisture content (LOD), water activity (aW), titrations, ID Testing (FT-IR), minerals quantification (ICP-MS).♦ Operation and troubleshooting of ICP-MS system.♦ Assist in conducting OOE, NCMR, CAPA and participate in root cause analysis.♦ Ordering of chemicals, consumable goods and laboratory supplies to maintain stock.KEY CONTRIBUTIONS:♦ Developing and implementation of a new testing method for Probiotics Enumeration to be performed by the in-house microbiology lab. Show less

• R&D Technician / Document Control

  • Sep 2009 - Oct 2011

  ♦ Maintain stock and inventory control for raw materials, excipients, reagents, containers, packaging and labeling supplies on R&D Lab.♦ Preparing, assembling, operating and maintaining of machines and process equipment according to SOPs.♦ Produce product prototypes, trail and pilot batches by using lab-scale machinery and equipment (blender, granulators, tablet press, coaters and encapsulators).♦ Performing special projects (process improvement studies)♦ Perform Document Control activities as processing Document Change Request (DCR), New Product Development Startup (NPDS), routing and tracking of documents, scanning, filing and maintenance of hard copy and electronic records for current and previous revisions.♦ Generating Product Label Information (PLI) by reviewing the formula, ingredient claims, excipients and nutritional facts.♦ Implementing improvements in document control system, creation of master files, forms and templates.♦ Assist in the review and signs off on customer product specifications.KEY CONTRIBUTIONS:♦ Design, development and maintaining a Nutritional Tool / Database to perform calculations of nutritional information for the new products and reformulations promptly and accurately. Show less

• Quality Control

  • Sep 2008 - Sep 2009

  ♦ Operation of standard laboratory and manufacturing equipment.♦ Perform data entry of all results generated in the QC Lab.♦ Perform pre-operational checks throughout production areas including swab testing for cleaning and sanitation validation in machinery, equipment and utensils.♦ Sampling and product inspection through manufacturing process to ensure compliance with quality requirements.♦ Testing of work-in-process and finished product for physical attributes: weight, hardness, thickness, friability, disintegration time, bulk density, tap density and particle size.♦ Sampling finished product for chemical assay, microbiological testing and stability studies.♦ Sampling for retention and maintaining the sample room.♦ Prepare product samples for physical, chemical, microbiology and stability tests. Show less



GRUPO INFRA MX

• Mexico
• Chemical Manufacturing
• 400 - 500 Employee

• Technical Sales Representative

  • Jun 2002 - Apr 2007



Bimbo do Brasil

• Food and Beverage Manufacturing
• 700 & Above Employee

• Production Supervisor

  • Jul 1999 - May 2002



Grupo Modelo S.A. de C.V.

• Mexico
• Food & Beverages
• 700 & Above Employee

• Production Supervisor

  • Mar 1997 - Jul 1999



Evaporadora Mexicana, S.A. de C.V

• Hermosillo, Mexico

• Production Supervisor

  • Sep 1994 - Dec 1996