Job Description

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