I am confident, detail-oriented with more than 15 years of establishing in-house quality standards and procedures. Results-oriented individual with a passion for continuous learning and innovation. Known for leveraging analytical thinking and creativity to solve problems and deliver high-impact solutions in fast-paced environments.
Overview
29
29
years of professional experience
1
1
Certification
Work History
Quality Management Specialist
Rauch North America-Red Bull
Phoenix, AZ
08.2023 - 04.2024
Planning, performing and participated in customer, internal and external audits, ISO9001, FSSC22000, BRC
Investigating and resolving CAPA’s for customer, internal and 3rd party audits
Ensuring ongoing abidance by industry regulatory and quality requirement FDA, ISO, GFSI, OSHA, CDC.,Kosher Lead and responsible for the quarterly traceability exercise ( Product Mock Recall)
Maintaining the recall plan, business continuity plan, crisis management, emergency response procedures
Working in SAP
Working on multiple projects at a time and flexible to other duties
Reviewing Supplier documents for supplier qualification
Reviewing and revising the Food Safety Plan
Providing operational support regarding the quality management system (QMS) to all departments
Group-wide (international and local) coordination with all departments on alignment with the QMS
Responsible for drafting and modification of documents, incl
Distribution and withdrawal of documents
Identified improvement potentials in the QMS and participated in the implementation
Managing and reviewing risk assessments to be compliant with BRC regulations
Ensuring GMP’s are followed and providing training 21Part CFR 117
Collaborating with other departments regarding quarterly internal audits and resolving problems
Supporting and consulting with all departments according to food safety and quality related topics
Implementation and training of the different quality tools and methods in use
Ensuring compliance with hygiene regulations, food safety requirements and quality standards
Training and awareness building of staff according to food safety and quality topics
Coordination and handling of deviations and complaints.
QA Manager
Precision Science
Phoenix, AZ
03.2022 - 09.2022
Responsible for developing and implementation of policies and procedures to ensure that quality standards are met
Ensuring the success of commercialization/Scale-Up production and management of all new and existing products
Collaborating with other departments to resolve customer complaints and launch new products
Ensure all aspects of handling, manufacturing and distribution of products comply with contract manufacturing agreements and meet relevant cGMP, regulatory and legislative requirements
Ensure compliance of product and process transfers, including validation, from and/or to other manufacturing sites
Responsible for creating and reviewing batch records and product release
Investigating and writing deviation investigations and customer complaints
Investigating and writing corrective actions
Worked with lab on stability program
Maintaining recall plan
Responsible for Change management
Working on multiple projects at a time
Investigating customer complaints and resolving issues
Overseeing established calibration and testing program and internal audit program
Maintain current knowledge of regulatory and legislative requirements/trends to ensure that expert advice and technical support on quality matters is provided, AAFCO, NASC, cGMP , 21 CFR Part 507, Part 225 and Part 226 Leads coordination and preparation of activities related to regulatory agency inspections FDA, EPA, Board of Pharmacy and customer audits Responsible for label claims and ensuring regulatory compliance in all food safety areas
Ensure that the quality department operates in a cost effective and efficient manner, harmonization with Operations
Provide leadership, direction and support to the people within the department and ensure that they are qualified Leads and coordinates the qualification and auditing of vendors and subcontractors
Has accountability for the company’s document control system and related processes
Creating and revising raw material and finish product specifications
Establishing and oversees the internal quality systems and policies throughout the company including all activities related to GMP, writing SOPs and training on existing and new SOP’s.
Quality Supervisor
HelloFresh
Phoenix, AZ
11.2021 - 03.2022
Ensuring a high level of internal and external customer service
Investigate (and correct) customer issues and complaints relating to quality
Performing internal audits
Develop and analyze statistical data and product specifications to determine standards and to establish quality and reliability expectancy of finished products
Coordinate objectives with production procedures in cooperation with other plant managers to maximize compliance, product reliability and minimize costs
Create, document and implement inspection criteria and procedures
Interpret quality control philosophy to key personnel within company
Maintain active role on internal continuous improvement teams
Design, develop and implement food safety training programs
Provide, and oversee, inspection activity for product throughout production cycle
Interact with vendors and procurement to ensure food safety of all purchased parts
Addressing nonconformities from previous internal and external audits
Conducting a management review of the food safety & SQF system when manger is out Following-up on and closing pending preventive and corrective action requests
Ensuring that organizational systems and training is in place
Ensuring that documentation and design controls are appropriate for organization
Administering document control and configuration management system
Overseeing established calibration and testing program
Assisting the management team and provide QA support when QA Manager is out
Provide all employees with necessary tools, proper training and corrective direction.
Project Manager/ Procurement Quality Coordinator
SunOrchard Juicery, LLC
Tempe, AZ
05.2019 - 04.2020
Project Manager for Implementing, Setup and Maintaining TraceGains Platform
Participated in weekly meetings with procurement, R&D, commercialization and quality in launching new products
Vendor Management and supplier qualification to ensuring regulatory compliance
Desk and on- site audits
Responsible for enhancing the vendor qualification program
Prepared for SQF and Kosher audits
Organized for GMO, Organic, Gluten Free, Kosher, Halal certification
Responsible for investigating and writing CAPAs
Investigating customer complaints
Participated in mock recalls
Maintaining Specifications for raw materials, labels and packaging
Working in “Genesis labeling software” to assist in launching new products
Create and approve label and packaging specifications in Genesis 21CFR part 101
Working with R&D on approving new ingredients to meet specifications
Teamed with packaging manager on creating new and revising packaging specifications
Teamed with supply chain group with providing new vendors with specifications
Worked with supply chain and new vendors daily to meet SunOrchard needs
Responsible for label review to meet FDA and regulatory compliance using Genesis
Responsible for change control and documentation control
Revising and editing SOP’s
Experience with ERP, Microsoft teams and SharePoint
Developing strong relationships with vendors, contract manufacturers and employees.
QA Manager
Olympian Labs, Inc.
Phoenix, AZ
04.2018 - 10.2018
Overseeing day to day operations of QA Department and QA technicians
Responsible for ensuring new product launches meet FDA and NSF compliance
Enhancing and developing QA systems per cGMP 21 CFR Part 111
Overseeing and implementing OSHA, PCQI, HACCP and cGMP compliance
Training employees on SOP’s and writing new SOP’s
Implemented stability program
Responsible for Change management
Responsible for maintaining quality standards and specifications for all products
Reviewing batch records including MMR’s, production and laboratory logs daily
Responsible for internal and external audits NSF/FDA/Vendor
Auditing suppliers
Working on multiple projects at a time
Responsible for QA manual, document control and change control
Responsible for the Implementation of vendor qualifications and stability program
Developing strong relationships with vendors and contract manufacturers
Investigating and writing CAPAS and Deviations for FDA and Olympian labs
Writing up Out of Specification (OOS) report when necessary
Responsible for label review, prop 65 and the DSHEA act to be compliant
Investigating customer complaints
Maintaining the recall plan and responsible for mock recalls
Overseeing Sanitation Program and conducting Sanitation and cGMP audits
Organized for GMO, Organic, Gluten Free, Kosher, Halal certification
Overseeing microbiological and pest control programs
Preparing reports for management and customers
Responsible for 5S and OSHA regulations
Working with SAGE software maintaining QA systems and working with e-signatures and e-records.
QA Coordinator
Albertsons/Safeway Ice Cream Plant
Phoenix, AZ
09.2017 - 01.2018
Performing PCQI duties for supplier approvals and batch record review
Maintaining and growing Food Safety plan
Responsible for doc control and working with e-signatures and e-records
Working with production and QA to ensure ongoing regulatory compliance
Participated with internal audits
Participated in mock recalls
Participated with external audits BRC, FDA, Organic, Kosher and Client audits
Responsible for document control and change control for audit preparation
Familiar with plant HACCP and FSMA requirements for plan
Assisting in bettering QA management system to meet FSMA requirements
Supervised and assisted QA techs where needed
Communicating with vendors and maintaining good relationships
Kosher Inspections with Rabbi
Responsible for 5S and OSHA regulations
Responsible for label review using Genesis
Calculated KPI scores associated with Kaizen/5S and SPC
Training employees in various SOP’s cGMP 21 CFR Part 117
Responsible to ensure employees are trained using the Alchemy training system.
QA/QC Lead Microbiologist
Marlyn Nutraceuticals
Phoenix, AZ
02.2016 - 08.2017
Managing Microbiology Lab
Implemented and Developed Environmental Monitoring Program
Performing environmental testing for water, swabbing and air
Enforcing cGMP 21 CFR part 111 in manufacturing area
Generating trend reports for environmental monitoring program results
Conducting analysis on raw materials and finish products for pathogens
Training of personnel in lab
Investigating root cause analysis for OOSI, incident reports and writing CAPA’s Document control
Participated in stability program
Researching new microbiology methods for laboratory
Ordering supplies for lab
Releasing and approving products that meet label claim and prop 65 Maintaining QA compliance with operators in the manufacturing facility
Writing SOPs
Generating certificate of analysis and working with e-signatures and e-records
Responsible for reviewing batch records including MMR’s
QA/ approving labels for production
FTIR.Loss on drying on raw materials, performing titrations and various chemical analysis on raw materials
ATP swabbing to verify cleaning
Performing testing using JP, BP, USP, EU, FCC, AOAC regulations.
QA/QC Lead Microbiologist
Best Life Pharmanaturals
Phoenix, AZ
10.2013 - 09.2015
Responsible for microbiology lab and training of personnel in lab
Ensuring QA compliance for GLP, prop 65 and cGMP 21 CFR Part 111
Conducting analysis on raw materials,in-process and finish products
Performed testing for Salmonella, S
Aureus, E.coli, coliforms, Total aerobic count, Yeast and Molds, PH
Conducted product hold alerts and investigated CAPA’s
Created Certificate of analysis (COA’s)
Participated in stability program
Researching various microbiology methods in laboratory
Ordering supplies for lab
Releasing and approving products
Responsible for writing SOPs and Training employees with various SOP’s
Document control
Responsible for environmental monitoring program
Responsible for reviewing batch records including MMR
QA/Approving labels for production
Assisted QA with implementing cGMP and FDA 21 CFR Part 111 regulations
Conducted internal lab audits and readiness for NSF audits
Communicated with clients daily to provide technical support and advice.
QA/QC laboratory Manager
Environmental and Analytical Management Inc. (EAM)
West Palm Beach, Florida
11.2002 - 05.2007
Manage microbiology laboratory and personnel
Accomplished set up of microbiology laboratory
Implemented ISO17025 to meet QA compliance
Root cause Investigation and writing of CAPAS
Responsible for QA AIHA external audit and document control
Assembled QA manual to obtain laboratory AIHA certification
Calculating results and originating client reports and COA’s (certificate of analysis)
Administered the training and hiring of technicians
Calibration and maintenance of equipment
Ordering of supplies and miscellaneous duties
Researched and developed various methods for bacteria and fungi
Write up SOP’s (standard operating procedures)
Conducting mold taxonomy and bacterial identification
Filled out chain of custody
Cultivated strong relationships with vendors and customers to enhance company needs
Communicated with clients daily to provide technical support and advice.
Microbiologist
South African druggists
Johannesburg, South Africa
05.1995 - 02.1999
Managed Nutritional, Pharmaceutical and Vitamin laboratories
Calculated results for release of product
Responsible for releasing product when supervisor was away
Responsible for communicating problems weekly to factory managers, after performing Environmental sampling in both nutritional and pharmaceutical facilities
Assisted in the training of new microbiologist
Assisted quality assurance manager in doing factory audits at suppliers
Implemented the validation of the Amersham ATP hy-lite monitor in factory
Presented Research Project to company managers and lecturers at institute
Validated and revised various SOP protocols to be implemented in the laboratories
Performed Environmental sampling and testing at nutritional and pharmaceutical factories
Tested raw materials, in-process and finished product for pathogenic bacteria to ensure quality control
Accelerated in performing vitamin assays
Tested for antibiotic assays and inhibitory substances
Performed Eliza tests to identify Listeria monocytogenes
Conducted use of API strips for proper identification of various bacteria
Tested for Total Plate Counts, Salmonella, Listeria monocytogenes, Yeast and Mold, Ecoli, Coliforms, B.cereus, S
Aureus, Clostridia
Conducted challenge tests
Operated Centrifuge, Spectrophotometer and PH meter
Validated all laminar flows which was part of quality control in all laboratories weekly.
Precision Science: Managing quality department, leading customer, FDA and State audits.
SunOrchard Juicery: Project Manager: Implementing and Maintaining TraceGains Supplier Qualification.
Olympian Labs: Lead and participated in NSF and FDA audits.
Albertsons Ice Cream: Participated in BRC, FDA and 2nd party audits. Enhancing Food Safety Plan.
Marlyn: Developed environmental program.
BestLife: Developed and implemented microbiology methods and environmental program.
EAM Labs: Certifying lab to AIHA audits and standards and earning Technical Manager title.
Infacare: Validated the Amersham ATP hy-lite monitor for use in manufacturing.
Volunteer Experience
Art of Living Foundation (USA), Project Manager, 2001-01-01, Present, Facilitating and organizing numerous Meditation and Breathwork Workshops. Motivating and maintaining good relationship with participants in an ongoing basis. Training volunteers and participants.
Boulder Creek Elementary School (Phoenix, Arizona), Volunteer, 2010-01-01, 2013-01-01, Mentoring and assisting students.
Timeline
Quality Management Specialist
Rauch North America-Red Bull
08.2023 - 04.2024
QA Manager
Precision Science
03.2022 - 09.2022
Quality Supervisor
HelloFresh
11.2021 - 03.2022
Project Manager/ Procurement Quality Coordinator
SunOrchard Juicery, LLC
05.2019 - 04.2020
QA Manager
Olympian Labs, Inc.
04.2018 - 10.2018
QA Coordinator
Albertsons/Safeway Ice Cream Plant
09.2017 - 01.2018
QA/QC Lead Microbiologist
Marlyn Nutraceuticals
02.2016 - 08.2017
QA/QC Lead Microbiologist
Best Life Pharmanaturals
10.2013 - 09.2015
QA/QC laboratory Manager
Environmental and Analytical Management Inc. (EAM)