PORSCHE QUALLS
Oak Forest,IL
Summary
Highly-skilled Director of Quality Assurance with comprehensive experience in developing and implementing quality assurance strategies. Strengths include adeptness at identifying process inefficiencies, fostering a culture of continuous improvement, and leading cross-functional teams to enhance product quality. Demonstrated success in delivering tangible improvements in previous roles, contributing significantly to the enhancement of customer satisfaction and business performance.
Overview
8
8
years of professional experience
Work History
Director of Quality Assurance & Food Safety
Vienna Beef
Chicago, Illinois
10.2022 - Current
- Ensure regulatory compliance with USDA (Exports), FSIS directives, FDA, SQF, Halal, OSHA, state and local authorities and acts as liaison with these agencies.
- Develop, lead, direct, update, reassessment, verification, and periodic validation of FSQA programs including HACCP program, Sanitation Standard Operations procedure, Pest Control, GMP, Approved Supplier Program, Foreign Material Control, Customer Complaints, Product Quality, Food defense and security.
- Managed and trained a team, Overseeing scheduling, recruitment, and ongoing performance development.
- Direct Recall and Traceability programs including Mock Recalls and internal/ external audits
- Create, review and approve internal and USDA labels.
- Develop, collect, monitor and maintain records
- Reviewed existing processes for identifying opportunities for improvement in efficiency, effectiveness, and accuracy.
- Monitored trends in customer complaints and returns to identify potential issues with product and service quality.
- Collected and analyzed production samples to evaluate quality.
- Established metrics for measuring performance against established goals.
- Achieved cost-savings by developing functional solutions to problems.
- Analyzed quality control data to identify trends, root causes of issues, and areas for improvement in processes and product quality.
- Collaborated with R&D teams to establish quality criteria for new products, ensuring design for quality and manufacturability.
- Established key performance indicators for evaluating the effectiveness of the company's quality management system.
- Implemented corrective and preventive action (CAPA) systems, significantly reducing defect rates and improving product reliability.
- Created reports detailing results from inspections, tests, investigations that were used by senior management for decision-making purposes.
- Prioritized and organized tasks to efficiently accomplish service goals.
- Managed inventory and supplies to ensure materials were available when needed.
- Conduct product quality checks along with third party send outs for testing
Quality Specialist /Microbiologist, Laboratory Quality Control
Bluetriton Brands -Nestle waters USA
Woodridge, IL
05.2021 - 10.2022
- Monitored and execution of testing activities, directing supervisors, inspectors and floor workers according to testing specifications to gather accurate, useful data.
- Completed routine sample processing, validations, state/ Federal/CAP and reagent QC runs.
- Conducted quality control checks, calibration and technical troubleshooting of all Chemistry and microbiology testing equipment.
- Managed departmental inventory and supply ordering.
- Preform routine operating and preventative maintenance of lab equipment . Preventative and corrective actions on non-conformities identified.
- compare, analyze and identify various organisms
- Support ISO/FSSC, IBWA, EPA, Hygiene Food safety and FDA audits
- Performing microbiological and chemical testing on all process and finished product samples.
- Ensure compliance/ record keeping for quality checks and sanitation. Created QA/QC reports, Interpret data.
- Primary plant liaison with customer service and affairs for quality complaints issues
- Received and inspected raw materials.
- Prepared and presented detailed reports on quality metrics, trends, and improvement initiatives to management.
- Prepared reports to communicate results of quality inspection activities to management.
Microbiologist-Aseptic /QC Analyst
Kashiv Pharma LLC
Chicago, IL
04.2020 - 04.2021
- Perform environmental monitoring in controlled and aseptic manufacturing areas.
- Perform routine monitoring for water for injection (WFI), reverse osmosis (RO), purified water (PW), and clean steam (CS) systems.
- Collect samples for the detection of viable (surface, gowning, and air) and non-viable air particles.
- Streaks and send representative EM isolates to contract lab for identification.
- Data entry for trend analysis, Deviations, Validations. investigation, Corrective and preventive actions (CAPA), risk / root cause analysis.
- Collect, submit and test samples for TOC, conductivity, microbial count and endotoxins using numerous USPs.
- Perform gram stain and growth promotion test.
- Perform tests for Bioburden , Drug product and microbial limit.
- Perform routine monitoring compressed air, and nitrogen gas for viable particles, non-viable particles, and moisture.
- Assisted with development and implementation of quality assurance policies, objectives and procedures.
- Audited training and production processes, enforcing adherence to SOPs. Authors and review SOP's.
Microbiologist/ Media/Diagnostic Technician
Merieux Nutrisciences Corporation -Silliker Lab
Crete, IL
10.2018 - 04.2020
- Logged all specimens, analyses, results and other data into LMIS.
- Prepare samples for analysis by recording, weighing and blending.
- Pipette and streak samples into tubes, agar plates and Petrifilm to identify bacteria.
- Track and monitor accurate quality control documentation and Assist in developing experimental designs, test plans and quality assurance.
- Utilize sterilization techniques via autoclave, ethanol and preform food poisoning, PH and growth readings and incubate/ refrigerate viable samples.
- Preform controls, gram stain and growth promotion test.
- Assist in developing experimental designs and test plans.
- Troubleshoot instrument problems.
- Conducted research on microorganisms for improving product quality and conditions.
- Demonstrate proficiency in Aseptic process environmental monitoring, Aseptic Testing, Microbial monitoring, Gram staining, and sub-culturing.
- Maintain knowledge of Laboratory Information Management System (LIMS), and SOPs that is required to complete job responsibilities audited production GMPs.
- Supervise daily operations of 25- 40 biological lab Technicians and served as team leader by scheduling and prioritizing work for staff and development training.
- Adhere to FDA standards of fortune five hundred companies.
- Performed aseptic techniques, listeria monocytogenes, testing for staphylococcus aureus, salmonella, Clostridium, bacillus cereus and lactobacilli.
Specimen Accessioner/Specimen Processing Specialist/Lab Assistant
Laboratory Corporation of America - LabCorp
Houston, TX
01.2017 - 09.2018
- Receiving, identify, sort, Prep, load/ unload and expedite specimen for testing.
- Review, transcribe and enter demographic/data entry / clinical processing of test requisition information.
- Respond and resolve instrument dialog errors and specimen issues.
- Centrifuge/ Separating /Handling/ Pouring all body fluids such as plasma, urine, blood, and serum.
- Distribute specimen to correct department by using name identifiers, date of birth and source of specimen and create labels.
- Managed production standards for both quality and quantity.
- Various other miscellaneous office and clerical duties.
- Supported work of pathologists by cutting, staining and mounting tissues samples for analysis.
- Processed over 1,000 hematology and chemistry samples daily, including manual reporting and quality reviews.
- Recorded control values from technical instruments to maintain reliability and validity of test results.
- Prepared specimens for in-house testing and for transport to off-site to reference laboratories.
Education
Bachelor - Biological Sciences
University of Illinois At Chicago
Chicago, IL2017
Skills
- Aseptic Gown Qualified
- All Microsoft and Google Applications
- Office administration/ clerical duties
- Coding and programming
- Aseptic technique and sterilization
- Cell Culture, PCR, Molecular and Cell Biology, Biotechnology, USP
- Laboratory Skills and (GMP) Good Manufacturing Practice
- Able to maintain turnaround time and on time delivery
- Ability to change direction, respond quickly and remain flexible
- Knowledge of laboratory tests
- Research and documentation
- Lab equipment calibration
- Process Validation
- FDA / EPA Regulations
- Quality Control Analysis
- Audit Processes
- Data Entry
- PCQI/ HACCP/CIP/ Crisis management/ FSPCA/ USDA/ SQF
- Allergen and Pathogen Control
Certifications
PCQI, HACCP, SQF, FSPCA, Allergen, Food Safety Manager, internal Auditor
Timeline
Director of Quality Assurance & Food Safety
Vienna Beef
10.2022 - Current
Quality Specialist /Microbiologist, Laboratory Quality Control
Bluetriton Brands -Nestle waters USA
05.2021 - 10.2022
Microbiologist-Aseptic /QC Analyst
Kashiv Pharma LLC
04.2020 - 04.2021
Microbiologist/ Media/Diagnostic Technician
Merieux Nutrisciences Corporation -Silliker Lab
10.2018 - 04.2020
Specimen Accessioner/Specimen Processing Specialist/Lab Assistant
Laboratory Corporation of America - LabCorp
01.2017 - 09.2018
Bachelor - Biological Sciences
University of Illinois At Chicago