•Conduct routine and non-routine analyses of in-process
materials, raw materials, environmental samples, finished
goods, or stability samples.
• Calibrate, validate, or maintain laboratory equipment.
Compile laboratory test data and perform appropriate
analyses.
•Complete documentation needed to support testing
procedures including data capture forms, equipment
logbooks, or inventory forms
•Evaluate analytical methods and procedures to determine
how they might be improved.
• Identify quality problems and recommend solutions.
• 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.
•Participate in out-of-specification and failure investigations and recommend corrective actions.
•Prepare or review required method transfer documentation including technical transfer protocols or reports.
• Receive and inspect raw materials.
•Review data from contract laboratories to ensure accuracy and regulatory compliance.
•Write technical reports or documentation such as deviation reports, testing protocols, and trend analyses.
•Supply quality control data necessary for regulatory
submissions.
• Develop and qualify new testing methods.
Evaluate new technologies and methods to make
recommendations regarding their use.
• Participate in internal assessments and audits as required.
• Perform visual inspections of finished products.