Elizabeth Florek

(Hired as QA & Regulatory Compliance Specialist promoted Feb. 2023)

• Cosmetic product production - batch records and all necessary documentation (hold, inspection, sampling, outsourced, testing, retention, release, CoAs) Stability Program, new formulations and new products created, testing, new documents, etc.
• Batch Records maintained for all cell derived products and aseptic fill qualifications.
• Cosmetic product line documentation working internally to create: Safety Data Sheets, Ingredients Lists, Stability Reports, Product Inserts, and all other documentation as requested by distributor and/or various country entities to expand our market.
• FDA Registration of facility and cosmetic products, working with distributor to obtain GMP Certification and Registration in 7 other countries.
• Lab equipment, including all validations, calibrations and certifications. Initiation, assignment, review, and approval of all documents created as required: logs/forms & SOPs for equipment, labs, cleanrooms and gown rooms. Coordinating, preparing, and documenting all necessary training and validation as applicable and document control.
• Coordinating, documenting, reviewing, training of all new employees and maintaining training files for all employees. Including onboarding of new personnel. Creating, revising, and updating all training forms and documents.
• Vendor/Supplier Qualification Program and Material Specifications for all items. Oversight of QC inspection and release of all products released into the lab.
• Oversee Environmental Monitoring Program including all controlled areas; cleanrooms and gown rooms as well as all Personnel monitoring. Oversight of cleaning and contamination control of all lab areas, cleanrooms and gown rooms.
• Environmental Health and Safety, coordinating safety training and inspections. Maintain and obtaining all facility certifications, permits and licenses as applicable.
• Documentation and QMS, creating and revising new forms, maintaining redlined copies and final versions of each. Oversee the assigning of investigations, deviations, CAPAs, Change Controls and tracking of each to ensure traceability and continual improvement throughout the company. Coordinating and documenting training new documents.
• Final review of all QC/Test Record Worksheets for the following: Endotoxin, Flow Cytometry, Sterility, pH, Osmolality, EM, PM, Dynamic Monitoring for Production. Review of stability testing, validation, new lot qualification. Oversight of bi-annual lab notebook review program for all scientists, R&D, and Quality lab personnel.

• Perform loan document signings for large companies and/or individuals.
• Responsible for contacting the clients, setting up appointments and obtaining the proper documentation from 3rd parties.
• Thoroughly review documents to insure all have been signed correctly.
• Return the documents and bill the appropriate companies.

• Perform Root Cause Analysis (RCA) and Corrective and Preventive Actions (CAPA). Author Deviation Reports and CAPA for manufacturing deviations from SOPs.
• Author and validate assay, process, design, and equipment protocols.
• Coordinate, analyze, and write final validation reports. Prepare stability reports and support documentation. Write detailed investigation reports for deviations.
• Create, maintain, and collect Certificates of Analysis (C of A) for purchase specifications.
• Conduct batch record reviews for product disposition and compare data with specifications. Review change control documents related to technical issues.
• Release in-process and finished products; maintain batch/lot number database. Perform additional Quality Assurance functions as assigned.
• Review and supply requested documents during FDA audits.
• Demonstrate strong documentation practices and writing skills in protocols and reports. Utilize computer skills, including Word, Excel, PowerPoint, and document management systems.
• Notarize necessary documents and/or contracts for distribution of products in other regions.

• Creating quality systems operational objectives by contributing information and analysis to strategic plans and reviews; preparing and completing action plans; implementing production, productivity, quality standards; identifying and resolving problems; responding to and acting on findings from both internal and external audits; determining system improvements and implementing change.
• Managing quality audits, CAPA, Root Cause Analysis; managing quality systems documentation including writing/revising SOP’s and conducting Internal Audits per ISO: 9001 standards.
• Quality control release testing
• Conduct lab tests on antigen purity using multiple assays and a full panel on ouchterlony as final testing.
• Conduct real time and accelerated stability testing on various products.
• Prepare chemical solutions, reagents for use in many processes; perform various laboratory tests; analyze and report findings, and investigate atypical results and discrepancies to determine cause.
• Maintenance, calibration and validation of AU400, AU600, Hitachi 911, Hitachi 711 etc.
• Expedite critical testing results without compromising sample validity or quality assurance. Creating work instructions and updating new findings to documents and product specifications.
• QC and R&D lab analysis performed such as turbidimetric immunoassays, ouchterlony, and immunoelectrophoresis to provide data for further processing or final release.
• Stringently followed lab protocols, sanitation standards and testing procedures.
• Immunizations performed on goats and venipuncture experience collecting blood for plasmapheresis and various samples.
• Hired as QC/QC Lab. Technician – promoted to Technologist and Sr. Technologist. Safety Team and Internal Audit Team

• Primarily doing inorganic extractions of soils, sludges and water samples.
• Testing for total recoverable metals by ICP.
• Perform the extractions as well as run the ICP.
• Experience with TOC/TOX, GC, UV/VIS, Liquid Chromatography and IR Spectrophotometry.
• In charge of preparing all reagents for the tests, preparing samples as well as setting up and running tests.
• Organized test results. Prepared, printed and presented reports.
• Experience preparing and performing diesel and organic extractions as well.