Stephanie Mayo Email and Phone Number

• Assist with Preventive Maintenance, Calibration, Qualification and troubleshooting of Analytical Equipment; HPLCs, Spectrophotometers, CEs, Balances, TOC analysers, PCR machines, Plate readers, etc. • Assist in implementation of data integrity policies especially for Lab Computer software (stand-alone and enterprise systems) to comply with regulatory guidance’s and requirements (e.g., 21 CFR Part 11).• Assist with drafting and/or peer review of Good Manufacturing Practice (GMP) documentation such as Standard Operating Procedures (SOPs), validation plans, user requirements specifications (URS), functional and design specifications (FS and DS), configuration specifications generation, testing protocols (IQ/OQ/PQ), user acceptance testing, traceability matrices, validation reports, risk assessment reports and change control documentation to support all validation activities per the validation master plan.• Assist with the design and execution of computer system validation (CSV) covering multiple computer and software platforms such as Empower, Softmax Pro, 32Karat, Gen5 Secure and ensure all new and existing electronic and/or computerized systems comply with all regulatory requirements.• Assist with the preparation of Requirement Matrix (RM) documents.• Execute or assist with execution of test plans according to approved procedures, collect samples, tabulate test results, and organize data packages.• Works on cross-functional project teams as required.• Stay up to date with industry best practices, industry benchmarks and FDA’s views regarding CSV and Analytical Equipment Validation.• Generate, review, and maintain the required documentation for pipette calibration activity in the QC labs per department SOPs.

• Maintain donor floor operations to include plasmapharesis donation procedures to ensure donor safety and quality of product• Supervise and perform venipuncture and plasma collection• Oversees the operation and maintenance of automated plasmapheresis machines• Maintain compliance with SOP, current Good Manufacturing Procedures (cGMP) and regulatory guidelines• Prepares weekly staffing schedules• Coordinates staff activities to increase efficiency• Performs performance reviews of donor floor staff• Educates new donors on the use of products made from donated plasma• Performs QA reviews of external sample/product shipment releases, training records, and deviation reports• Ensures the Donor Center’s licenses and certificates are in-date and valid• Performs audits for self-assessment evaluation, monitor records, and overall compliance related to the company quality systems• Attends and assist in all audits and ensures that all audits (internal and external) are performed, documented, reviewed, and closed.• Assists in maintaining the established quality system under any requirements that affect the center and help ensure that all operations in the center are in compliance with the company’s quality program• Assists in, conducts, and evaluates center training and orientation program

Process red cell and platelets collections that the Oklahoma Blood Institute (OBI) receivedPrepared and ran samples on flow cytometer (BD FACScalibur) and hematology (sysmex) instruments Ordered, handled, and organized supplies and reagents used in the laboratory Entered and reviewed documentation pertaining to testingFollowed laws pertaining to HIPAA, CLIA, AABB and FDA guidelinesTrained new employeesMaintained QC spreadsheetsRan and updated monthly spreadsheets

Prepare patient sample for data entry. Enter patent information into LIMS system. Pipet samples. Preparing patient samples for the LC/MS machines, preparing standards and quality controls, preparing solvents, and analyzing and verifying patient results.Preparing samples for AU640, AU640 operation and maintenance. Follow SOP, HIPPA, CLIA and COLA guidelines.

Opening and closing registers, opening and closing procedures for the store, making sure department stays stocked, setting products to layout designs, customer service, visual merchandising, maintaining current knowledge of procedures, applying appropriate marketing, assisting loss prevention, coaching associates on policies and procedures, keeping up with layaways, teaching associates about the importance of credit cards, and the Gordmans reward program.

Assisting customers with purchases, maintaining current knowledge of procedures, remaining current on company policies, taking telephone orders, processing shipments, filling out associate paperwork, running cash registers, overseeing floor sets, opening and closing the store, helping assistant managers and store managers with day to day operations.

Interaction with residents of the facility, preparation and cooking of baked goods, taking orders from residents of the facility, delivering orders, clearing and setting tables, washed dishes, washed linens, ensured proper sanitation of utensils and facility, assisted with salad bar, ect

Assisting customers with purchases, running a cash register, taking phone calls, remaining knowledgable about store, processing shipments, store replenishment, basic cleaning, opening and closing procedures.