Fowler
Associates for all electrostatic testing, consulting and training
needs. "You got questions. We got answers!" |
Radio-Pharm
Quality Manager Provide
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
budgetary requirements. 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. Works directly
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
system. Update and issue plant-wide batch records, STM's, SOP's and specifications.
Provide performance feedback and coaching for quality personnel.
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