Quality Management Assurance

Tyra L VanLeer

*** ******* ** *** #*

Mansfield, Ohio 44907

614-***-****(cell)

************@*****.***

Summary of Qualifications

● Significant investigative skills to determine risks and problems in order to make sound conclusions and recommendations

● Demonstrated ability to work independently and as a team member to achieve agency goals and objectives

● Ability to effectively communicate with customers, coworkers, and management at all levels

● Possess exceptional ability to investigate information, develop critical analysis and make recommendations

● Computer proficient using Microsoft Office including MS Word 7.0 and MS Outlook, Oasis, and Facts

● Proficient in QS/9000 standards

Professional Experience

Independent/Licensed Insurance Agent Contractor Columbus, OH

Sell Life & Health Insurance June 2023-2025

Ancient Nutrition Franklin, TN

Quality Manager November 2018-March 2019 Manager

• Reviewed customer complaints and documented information on adverse event report log.

• Documented returned dietary supplements that had quality issues. Forward corrective action report forms to CMO (contract manufacturing organizations).

Food, Safety & Drug Investigations Planning & Development Microbiology Investigations Managerial Leadership Advance Interpersonal Communication Negotiating Workplace Shift Behavior Practice EPA Wastewater Collection Complaint Investigations OSHA Compliance Certification Microsoft Office Quality Assurance Power Point Level 1 Quality Management Power Point Level 2 Bloodborne Pathogens Certificate Adult, Child and Infant CPR First Aid

• Addressed customer complaints related to their concerns about their dietary supplements related to quality issues: (off color, taste and/or appearance.)

• Documented and photographed returned dietary supplements that customers returned, which had visible color variations in the dietary capsules and/or the dietary supplement bottles contained empty capsules.

• Requested SDS’s for raw material manufacturers and the information was placed on Ancient Nutrition SDS’ sheet.

• Conducted sensory testing on returned products to verify and/or validate whether the dietary supplements were within specification and confirm whether the CMO retain sample was comparable to the returned product from the customer. The CMO, was informed to provide additional feedback, if any discrepancies were noted during the production run or, if the retain sample had an: (off taste, color and/or appearance).

LARA (Licensing and Regulatory Affairs) Lansing, MI

State Surveyor August 2017-September 2018

• Knowledge of agency, state, and/or federal laws, rules, and standards governing the

• operation of health care facilities.

• Knowledge of survey design, inspection, and review procedures and processes for

• Knowledge relative to evaluation of quality of care in environmental health, sanitation, • dietetics, nursing, pharmacy, speech therapy, psychology, occupational therapy,

• Physical Therapy, Respiratory Therapy, and/or Social Work.

• Ability to conduct surveys in applicable professional discipline(s).

• Ability to observe critically and recognize areas of non-compliance, problems, and discrepancies.

• Ability to interpret and apply complex laws, procedures, rules, and regulations.

• Ability to review and examine complaints.

• Ability to handle routine and sensitive contacts with staff and officials of health care

• Facilitate in a professional manner.

• Ability to define and collect data related to problems in facilities.

• Ability to maintain records, and prepare reports

Rich’s Product Hilliard, Ohio

Quality Assurance Team Leader November 2015- January 2017

• Supervise 5 direct reports QA lab technicians.

• Mentor and motivate Associates, providing training and development

• Monitor the quality of all products being manufactured at the manufacturing facility

• Work with R & D with batches, data, and sample collection

• Ensure that hold policies and procedures are communicated to plant staff • Determine whether hold products should be released, reworked and/or dumped.

• Monitor hold, rework and dump logs

• Review QA testing results in QDMS (Quality Data Management System)

• Verify formula specifications in PLM and track finished product in SAP.

• Monitor SOP’s and methods for performing task

• Update SSOP/GMP- best practice standards (keep equipment and area cleaned and sanitized)

Liqui-Box Upper Sandusky, Ohio Quality Facilitator January 2015- August 2015

• Revised Quality PQCT bag specifications, testing frequencies and procedures

• Ensure that quality product standards are placed on hold

• Input statistical data in mini tab to graph results

• Participated in weekly meetings to go over the mini-tab graph results and determine the percentage of rework being used contributed to defective parts

• Conducted plant trial runs on new bag-in-box fitments

U.S. Food Drug Administration College Park, MD Consumer Safety Officer January 2013- January 2014

• Write recall strategy recall notification letters

• Assess the health hazard of a recall product

• Request additional information about potential and/or ongoing recall situations from industry.

• Verify whether the supporting documents and/or spreadsheets match the information that was submitted to CFSAN

• Knowledge of EPA’s regulations on pesticide residue tolerances for food and of EPA’s drinking water standards

• Sufficient skill in applying regulatory and scientific knowledge in evaluation and preparation of regulatory actions and related documents

• Skill in planning and/or implementing enforcement strategies that require input and cooperation from diverse groups

• Access Quality Management System

• Verify (Master Sanitation Schedule)

• Inspected and reviewed the firms GMP's, SSOP's and SOP's practices

• Review personnel training records

• Travel to food processing facilities within Ohio and Michigan and conduct food safety audits and SQF/Audits

• Traveled to different food supplier locations to perform audits.

• Prepare reports detailing quality, safety and product issues for customers.

• Implement GMP’s SSOP's, SOP's and sanitation practices which are in compliance with FDA regulations

• Monitor pest control procedures

• Assess Daily Sanitarian Log Sheets

• Implement daily, weekly, cleaning assignments

• KPI Reporting

• Implement Master Sanitation Cleaning Schedules

• Lock Out/Tag Out (OSHA) Audits

• AIB Certification

• SQF Certification

• Chemical Safety Training (Titration)

• Conducted GMP’s, SSOP’s, and SOP’s audits

• Personal Protective Equipment

Independent Food Safety Consultant Ohio, Michigan, Nebraska Food Auditor 2011-2012 QSI/Swedish Match Owensboro, Kentucky Account Sanitarian August 2010- April 2011

• Conducted Food Safety inspections, evaluated GMP’s, SOP’s and sanitary practices.

• Safety audit checks throughout the manufacturing facility to ensure proper lockout/tagout, OSHA GEMBA walk thru

• Collected water samples, inspected floor drains, conducted chemical titration, collected wastewater to ensure permissible EPA limits.

Kellogg’s Zanesville, Ohio Quality Supervisor November 2011-April 2012

• Drive continuous improvement in the areas of plant efficiency

• Conducted Food Safety and GMP Audits

• Monitored the pest control program

• Conducted Associate training on GMP and Food Safety policies and procedures

• Conducted environmental micro swabbing in the plant

• Supervised 7 direct reports QA Technicians

U.S. Food and Drug Administration Detroit, Michigan

Consumer Safety Officer March 2005- July 2009

• Audits, review and evaluate the manufacturing processes of products that the FDA regulates by inspecting manufacturing facilities within the United States

• Conduct food safety audit checks which consist of reviewing quality management standards; related to HACCP standards, GMP’s and sanitation practice

• Inspect and/or investigate quality control standards in reference to the food manufacturing process, to ensure the manufactured food is wholesome.

• Investigate food safety management systems, to ensure the food supply chains follow the U.S. Food & Drug Administration by laws

• Reviewed manufacturing food firms, food quality assurance and quality management standards

• Conducted food safety and/or quality management audit checks at dairy manufacturing facilities (Middle Eastern) yogurt and goat cheese processing plants

• Developed and implemented a quality assurance system for a wide range of imported products

• Enforced operational standards related to federal regulatory laws

• Assessed quality control test on materials and part batches; concerning temperature control measures that must be followed during the HACCP processing phase

• Investigates complaints of violations FDA’s laws, injuries, to consumers and illnesses involving FDA regulated products

• Collects samples of FDA products (produced domestically and/or foreign parties) or other items for laboratory testing or as evidence in FDA related cases

• Audits documents generated by a company’s research, which support an application to the FDA to permit the marketing of drugs or medical devices

• Communicates information about the laws and policies of the FDA to consumers, industry, and related government agencies in the interest of the promotion of public health

• Works as a multidisciplinary team to assure efficient enforcement, which consist of representatives from Department of Justice, United States Bureau of Customs and Border Protection, United States Department of Agriculture, and state and local governments to name a few

• Performed quality control for fit testing through Michigan Occupational Safety Health Administration for full-face respirators

Toledo Lucas County Health Department Toledo, Ohio

Sanitarian/Health Inspector January 2000- February 2004

• Prepared reports on food service operations when a violation of the Ohio Uniform Food code has been detected

• Inspect buildings to determine whether each facility is following EPA regulations, OSHA regulations and HACCP standards

• Conduct seminars on how to handle biological terrorism and Emergency Response • Responsible for enforcing the RCRA, and CERLA regulations.

• Write technical OSHA-300 log sheet reports on work-related injuries and illnesses

• Inspected Marinas holding tanks to ensure that the wastewater was being properly treated

• Monitored wastewater tanks at mobile home parks and/or RV parks

• Inspected commercial food license trucks to ensure that the water was being discarded in wastewater bin (Blue-boy)

• Collected water samples of behalf of the EPA at campgrounds, marinas, and mobile home parks

• Inspected campgrounds to ensure that the facility was using a proper water supply and proper sewage disposal.

Lucas County Mental Retardation Toledo, Ohio

Developmental Disabilities (Lott Industries) June 1991-December 1999

Rehabilitation Specialist

• Supervised 30-40 mentally disabled clients who were responsible for assembling Ford products

• Assessed quality control methods on all finished products

• Assessed everyone to determine appropriate working capabilities

• Prepared and compiled reports related to each assessment

• Intervened between clients, when necessary, who displayed aggressive behavior during work

• Assembled Ford Motor F-150 pair Wheel Well guard at Lott Industries

• Conduct Quality Control and inspected finished preassembled Wheel wells that were assembled by Lott Industries contracted employees

• Received on-the-job training ISO- 9001 and QS-9000 standards for Ford Motor automotive parts.

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Affiliations

• Member of National Environmental Health Association

Education

Lourdes College, Toledo, Ohio Graduated June 1999

Bachelors of Natural Science

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