Quality Control Analyst I

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