Registration & Compliance Manager

• Aug 2023 - Present

New Product Project Manager

• Sep 2020 - Aug 2023

Manages the project lifecycle for all new product development projects, including stakeholder communications. Develops new process instructions, coordinates production trials, and advises on capital equipment installs. Conducts competitive analyses, and coordinates cost analysis and GLP studies for product launch. Knowledge of Project Management Software (i.e. Wrike, Microsoft Project)Update and track project calendars/progressFacilitates product launches at the state levelDevelops Safety Data Sheets using Lisam Software Manages state and federal required submission (tonnage, mill tax, sales report, tier II reports, EPA establishment report, etc.) Show less

Registration and Compliance Associate

• Jul 2018 - Sep 2020

QC Lab Supervisor

• Dec 2017 - Jul 2018

Oversee corporate management control advisory services for accounts totaling $100,000 in the compliance department. Manage organizational compliance testing and reviews for operational controls, business processes, internal control management, and audit readiness support for 1950 annual claims. Supervise complex compliance projects including program management support for external audits, researching new compliance and quality assurance standards and identifying opportunities for overall operational efficiency. Introduce recommendations to overcome weaknesses and mitigate associated risks. Perform work as part of an integrated managerial operational team performing analysis and providing recommendations. Identify weaknesses in internal control procedures and assess the adequacy of liability and operating controls. Develop, maintain and update data entry standards and procedures to capture medical data and validation. Define and analyze operational problems and pose options and alternatives to existing procedures. Formulate, coordinate and publish quality guidance to resolve problem issues, expedite actions, implement new initiatives, improve processes, and facilitate the accomplishments of program objectives. Perform full process mapping of claim activities and carry out operational audit procedures on the different cycles. Responsible for developing, documenting and maintaining design history files. Show less

QC Lab Supervisor

• Apr 2016 - Dec 2017

Oversee corporate management control advisory services for accounts in the compliance department. Manage organizational compliance testing and reviews for operational controls, business processes, internal control management, and audit readiness support for annual claims. Supervise complex compliance projects including program management support for external audits, researching new compliance and quality assurance standards and identifying opportunities for overall operational efficiency. Introduce recommendations to overcome weaknesses and mitigate associated risks. Perform work as part of an integrated managerial operational team performing analysis and providing recommendations. Identify weaknesses in internal control procedures and assess the adequacy of liability and operating controls. Develop, maintain and update data entry standards and procedures to capture medical data and validation. Define and analyze operational problems and pose options and alternatives to existing procedures. Formulate, coordinate and publish quality guidance to resolve problem issues, expedite actions, implement new initiatives, improve processes, and facilitate the accomplishments of program objectives. Perform full process mapping of claim activities and carry out operational audit procedures on the different cycles. Responsible for developing, documenting and maintaining design history files. Show less

Quality Control Analyst

• Aug 2014 - Apr 2016

Ensure quality of promotional products and product safety. Perform inspections of finished products using an XRF machine. Participate in internal assessments and audits as required. Serve as a technical liaison between quality control and other departments, vendors, or contractors. Coordinate testing with contract laboratories and vendors. Write or revise standard quality control operating procedures. Participate in out-of-specification and failure investigations and recommend corrective actions. Identify quality problems and recommend solutions. Interpret test results, compare them to established specifications and control limits, and make recommendations. and the production team to produce high-quality reference standards. Conducted QC testing on raw materials, materials in process, and finished product. Selected appropriate established methods and procedures, performed analytical tests and accurately maintained data documentation. Executed routine analytical tests at each stage of production to determine and establish material quality and compliance with established Reference Standard (RS) specifications. Supported daily operational functions of the production environment by performing pivotal quality checks, verifying station/line clearances, and performing required fill weight verifications of lots during production. Worked in a cross-functional capacity to resolve testing issues and communicate material quality issues to scientific staff and QA. Completed routine statistical calculations and generated scientifically sound, reproducible, and accurate data. Assisted in the design, implementation, and validation of new procedures for testing and evaluating the precision and accuracy. Supported in the validation of new instruments, QC methods, and techniques. Entered data evaluated for compliance to specifications and reported abnormalities. Coordinated testing with contract laboratories and vendors. Show less

Certified Nurse Aide

• Nov 2012 - Dec 2014

Specimen Processor

• Jan 2013 - Oct 2013

Process laboratory specimens for testing Handle specimens properly in an independent manner Process laboratory specimens for testing Handle specimens properly in an independent manner

Lecture and Teacher's Assistant/ tutor

• Jan 2008 - May 2011

Provided guidance to fellow student in specific chemistry courses Provided Quality Assurance and regulation of instrumentation and laboratory procedure to students Aid teacher's with grading, lectures and tutoring of students Collaborated with professional teachers to aid student learn the subject at hand. Responsible for knowing the general laboratory techniques, procedures and methods, including sample collection and preparation for instrumental analysis. Responsible for knowing the properties and characteristics of various chemicals used in a laboratory. Ensured sanitation and sterilization of equipment and devices followed in a chemical laboratory. Show less

Intern

• Jan 2008 - Jul 2008

Assisted pathologist assistant and student with various autopsy services including macroscopic and microscopic examination Became familiar with the terminology, standard abbreviations and the types and uses of equipment used in a laboratory Knowledge of sanitation and sterilization of equipment and devices and the methods, techniques and procedures followed in a laboratory Became familiar with the proper methods used in the disposal of contaminated materials and laboratory safety Utilized the intern manual, office personnel, and office resources as references and guidelines. Show less