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19-4099.01 — Quality Control Analysts

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	Conduct routine and non-routine analyses of in-process materials, raw materials, environmental samples, finished goods, or stability samples.
	Interpret test results, compare them to established specifications and control limits, and make recommendations on appropriateness of data for release.
	Calibrate, validate, or maintain laboratory equipment.
	Ensure that lab cleanliness and safety standards are maintained.
	Perform visual inspections of finished products.
	Complete documentation needed to support testing procedures, including data capture forms, equipment logbooks, or inventory forms.
	Compile laboratory test data and perform appropriate analyses.
	Identify and troubleshoot equipment problems.
	Write technical reports or documentation, such as deviation reports, testing protocols, and trend analyses.
	Investigate or report questionable test results.
	Monitor testing procedures to ensure that all tests are performed according to established item specifications, standard test methods, or protocols.
	Identify quality problems and recommend solutions.
	Participate in out-of-specification and failure investigations and recommend corrective actions.
	Receive and inspect raw materials.
	Train other analysts to perform laboratory procedures and assays.
	Supply quality control data necessary for regulatory submissions.
	Serve as a technical liaison between quality control and other departments, vendors, or contractors.
	Write or revise standard quality control operating procedures.
	Participate in internal assessments and audits as required.
	Perform validations or transfers of analytical methods in accordance with applicable policies or guidelines.
	Evaluate analytical methods and procedures to determine how they might be improved.
	Prepare or review required method transfer documentation including technical transfer protocols or reports.
	Review data from contract laboratories to ensure accuracy and regulatory compliance.
	Develop and qualify new testing methods.
	Coordinate testing with contract laboratories and vendors.
	Evaluate new technologies and methods to make recommendations regarding their use.