QUALITY CONTROL ANALYST

Job Definition:

Job Description:

• Conduct tests to determine quality of raw materials, bulk intermediate and finished products. May conduct stability sample tests.

Duties and Tasks:

• 1) Ensure that lab cleanliness and safety standards are maintained.
• 2) Develop and qualify new testing methods3) Train other analysts to perform laboratory procedures and assays.
• 4) Perform visual inspections of finished products.
• 5) Participate in internal assessments and audits as required.
• 6) Identify and troubleshoot equipment problems.
• 7) Evaluate new technologies and methods to make recommendations regarding their use.
• 8) Serve as a technical liaison between quality control and other departments, vendors, or contractors.
• 9) Coordinate testing with contract laboratories and vendors.
• 10) Write technical reports or documentation such as deviation reports, testing protocols, and trend analyses.
• 11) Write or revise standard quality control operating procedures.
• 12) Supply quality control data necessary for regulatory submissions.
• 13) Receive and inspect raw materials.
• 14) Review data from contract laboratories to ensure accuracy and regulatory compliance.
• 15) Prepare or review required method transfer documentation including technical transfer protocols or reports.
• 16) Perform validations or transfers of analytical methods in accordance with applicable policies or guidelines.
• 17) Participate in out-of-specification and failure investigations and recommend corrective actions.
• 18) Monitor testing procedures to ensure that all tests are performed according to established item specifications, standard test methods, or protocols.
• 19) Investigate or report questionable test results.
• 20) Interpret test results, compare them to established specifications and control limits, and make recommendations on appropriateness of data for release.
• 21) Identify quality problems and recommend solutions.
• 22) Evaluate analytical methods and procedures to determine how they might be improved.
• 23) Complete documentation needed to support testing procedures including data capture forms, equipment logbooks, or inventory forms.
• 24) Calibrate, validate, or maintain laboratory equipment.
• 25) Compile laboratory test data and perform appropriate analyses.
• 26) Conduct routine and non-routine analyses of in-process materials, raw materials, environmental samples, finished goods, or stability samples.

Activities:

Abilities:

Knowledge