for all electrostatic testing, consulting and training
needs. "You got questions. We got answers!"
direction for domestic and foreign cGMP requirements for manufacture, test and
release of current product lines
(produces the radioactive material Tc-99m;
Thallium 201, Iodide I-131, Xenon Gas, Gallium)
Lead continuous improvement
efforts to reduce cost, increase operational efficiency and improve quality.
Manage Quality Department in accordance with regulatory compliance and
Coordinates with R&D, Marketing and Manufacturing
introduction of new products.
Responds to regulatory concerns from the
following: FDA, EPA, USDA, DEA,
HPB, DH, State, County and local ordinances.
Manages vendor program to assure adequacy of vendors.
with operation entities to ensure that inspections, statistical process control
analyses and audits are conducted on a continuing basis as specified to enforce
requirements and meet specifications.
Maintain a controlled document
Update and issue plant-wide batch records, STM's, SOP's and specifications.
Provide performance feedback and coaching for quality personnel.