Dominick Miller

•Efficiently and accurately optimizing components of AtheNA Multi-Lyte kits.

•Following all necessary procedures and accurately recording production in compliance with FDA regulations.

•Keeping the laboratory clean and safe, properly disposing of biohazardous waste, and following all necessary precautions.

•Antigen dialysis, titrations, and couplings. Positive and negative control optimizations. Plasma defibrillations. Optimizing new serum panels and antigens as needed. Conducting bulk testing on contracted assays as required.

•Practicing the indirect fluorescent antibody (IFA) technique, to detect the presence of ANA in the sera of patients with systemic lupus erythematosus (SLE), and other clinically similar connective tissue disorders.

• Completed necessary documents following Good Documentation Practices (GDPs) and complied with cGMPs and company ISO standards to ensure accountability and traceability of the product.

•Completed documentation of activities according to established procedures, including attaching label specimens, and reconciling material printed with variable data.

•Conducted equipment calibration checks and resolved any issues with the equipment as needed.

• Notified production management of any quality deviations from established processes or procedures regarding compounded IV bags/syringes immediately.