Quality Manager - Candidate OG 102218

 

quality manager

  • BS in Science, Microbiology, 10 years exp with quality management
  • HACCP Certified for 4 years
  • Implements quality systems in the Plant, meets with FDA on Sanitation issues, etc.
  • Performed tests on Raw materials while working as a microbiologist (since 2010)
  • Promoted 4 times at current company
  • Managed teams up to 7 people, manages Vendors
  • Company relocated him after closing operations in one state
  • Good career stability, Good communication skills – articulate, patient, personable
  • Has a passion for the Food Industry
  • Fully bilingual in English and Spanish – verbal and written
  • Single, renter, no kids, easy relo

 

SUMMARY

Experience microbiologist in food science and skin care cosmetics field with proven success in productiveness to meet date lines. Key skills in leadership, microbial testing, problem solving, and training, detailed oriented with strengths in:

Microbial testing Training
Quality control/assurance Method Validation
ISO/IEC 17025 Project management
FDA, USDA, USP, CTFA methodology Cleaning Validation
Compliance Process Validation
CA/PA  

 

EXPERIENCE

MAJOR US COSMETICS COMPANY 2016 – PRESENT

QUALITY ENGINEER 2018 – PRESENT

Major US Cosmetics Company Earning $80K

  • Support achievement of key metrics, including quality, safety, productivity, cost and employee development, through process change and improvement - Shower gels, creams, fragrances, nail lacquers
  • Responsible for Quality System Maintenance
  • Assist Quality Manager in establishing, implementing and maintaining Quality Management System
  • Develop process related quality procedures, training materials and assist in implementation
  • Interact with New Product Development, Packaging Concept Development, Technical Packaging Development, Engineering and Manufacturing to ensure effective implementation of new products
  • Complete Quality Reports (Executive Summary reports, Process Validation Protocols/Reports, Equipment Validation Protocols/Reports, etc.)
  • Root Cause Analysis and Implementation of corrective/preventive actions for Non Conformances/process related concerns
  • Apply process improvement tools including statistical process control, process mapping, control charts, design of experiments, Lean methodology and process capability studies
  • Initiate and develop appropriate SOPs, Work instructions, Std Work etc. with effective training to employees
  • Define and develop process opportunities to reduce costs and to maximize productivity
  • Work with Supplier Quality Engineer and create link between operational requirements and material supplier capabilities
  • Define key critical parameters and develop plans to control and improve
  • Implement and sustain data driven improvements
  • Develop and document processes (Process Flow Diagrams)
  • Evaluate and improve packaging processes

 

MICROBIOLOGIST 2016 – 2018

Major US Cosmetics Company

  • Chair of the Chemical Hygiene Committee as the Chemical Hygiene Officer.
  • Review and implement Chemical Hygiene Plan to remain current on legalities concerning chemical use.
  • Monitor procurement, use, disposal and inventory of chemicals used.
  • Responsible for maintaining appropriate equipment in laboratories.
  • Helped with the transition of Philosophy to Major US Cosmetics Company from Phoenix, AZ to Sanford, NC and moved for the company as a microbiologist
  • Led and participated in projects to assure quality in products Including Cleaning validation.
  • Perform microbiological testing on bulk, finish products, raw materials and customer complaints in accordance to SOPs.
  • Update and create new SOP to facilitate testing and validations
  • Responsible of environmental monitoring of plant and RO/DI water system
  • Responsible of the release finished products for shipments, raw materials for usage and bulk for filling.
  • Work closely with R&D to perform PET testing on products.
  • Performing various identification tests
  • Recognize and identify organisms that are in contaminated product and could be harmful for consumer use.

 

MICROBIOLOGIST 2014 – 2015

Major US Cosmetics Company

  • Perform microbiological testing on bulk, finish products, raw materials and customer complaints in accordance to SOPs.
  • Update and create new SOP to facilitate testing and validations
  • Responsible of environmental monitoring of plant and RO/DI water testing
  • Perform validations for media, autoclave, finish goods and CELSIS rapid detection system.
  • Responsible of the release finished products for shipments, raw materials for usage and bulk for filling.
  • Work closely with R&D, compatibility and stability to perform microbiological testing on current testing products.
  • Recognize and identify organisms that are in contaminated product for consumer use.
  • Use CELSIS advance system to screen products for contaminants and perform validation studies on current products.

 

FOOD SAFETY & QUALITY LLC 2010 – 2014

  

LABORATORY TECHNICIAN III 2013 – 2014

Food Safety & Quality LLC

During a 4 year employment - was promoted from Tech I – Tech II/Master trainer and to Tech III

  • Supervised technicians as part of the Manager on Duty program.
  • Help coordinate proficiency testing.
  • Perform QA/QC on laboratory documents, machinery and techniques to ensure quality through the laboratory.
  • Familiar with CA/PA procedure to ensure uniformity and compliance with ISO/IEC 17025
  • Review SPC charts and monitor the LCS program.
  • Prepare documentation according to ISO/IEC 17025 and A2LA guidelines to facilitate external audits.
  • Perform sample assays for Listeria monocytogenes, Listeria species, Salmonella species, Salmonella enteritidis E. coli O157:H7, non O157 E. coli testing, E. sakazakii and shiga toxins by Vidas Automated Immunoassay Analyzer, Bax, GDS, and EIA.
  • Perform cultural confirmation of test result according to FSIS, FDA, USDA, APHA, AOAC, and MLG.
  • Contact clients and discuss test results.
  • Data entry, tertiary review of CoA

 

LABORATORY TECHNICIAN II, MASTER TRAINER 2011 – 2013

Food Safety & Quality LLC

Monitor the training program by training new and existing employees on different methods and techniques used to test clients samples according to ISO/IEC 17025 guidelines

  • Perform annual continuing training on existing employees through class training and mock sample testing
  • Help coordinate proficiency testing.
  • Perform QA/QC on laboratory documents, machinery and techniques to ensure quality through the laboratory.
  • Perform sample assays for Listeria monocytogenes, Listeria species, Salmonella species, Salmonella enteritidis E. coli O157:H7, non O157 E. coli testing, E. sakazakii and shiga toxins by Vidas Automated Immunoassay Analyzer, Bax, GDS, and EIA.
  • Perform cultural confirmation of test result according to FSIS, FDA, USDA, APHA, AOAC, and MLG.
  • Contact clients and discuss test results.
  • Data entry, tertiary review of CoA
  • Count and record plates for colonies
  • Perform opening procedures end of day Quality Control for Pathology lab
  • Maintain quality control and maintenance of various Laboratory equipment and stock cultures according to ISO/IEC 17025

 

LABORATORY TECHNICIAN I 2010 – 2011

Food Safety & Quality LLC

  • Perform sample assays for Listeria monocytogenes, Listeria species, Salmonella species, Salmonella enteritidis E. coli O157:H7, non O157 E. coli testing, E. sakazakii and shiga toxins by Vidas Automated Immunoassay Analyzer, Bax, GDS, and EIA.
  • Perform cultural confirmation of test result according to FSIS, FDA, USDA, APHA, AOAC, and MLG.
  • Set and prepare samples for microbiological testing according to FDA-BAM, Compendium, ELFA, USDA, APHA, GLP, MLG, AOAC, and FSIS Methods for various organisms including: EC. O157:H7, Listeria, Salmonella, Bacillus Cerus, Streptococcus, Aflatoxin and Vomitoxin
  • Plate samples for APC, SPC, HPC, YM, EB, EC, CC, Lacto bacillus, Staph, Bacillus cereus, Clostridium, Pseudomonas, Psyhcotrophics Thermophilic, Thermophilic spores, Mesophilic, FDA-Bam, AOAC , TEMPO plating most probable number and compendium.

 

LANGUAGES

Bilingual in English and Spanish: fluently write, read and speak Spanish

 

EDUCATION

Bachelors of Science, Life Sciences, Arizona State University, Phoenix, AZ, 2006-2010

Associate of Science, Biology Emphasis, Glendale Community College, Glendale, AZ, 2004-2006

 

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