Fowler Associates
for all electrostatic testing, consulting and training needs.
"You got questions. We got answers!"
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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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