What do Quality Control Analysts do?
Conduct tests to determine quality of raw materials, bulk intermediate and finished products. May conduct stability sample tests.
- 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.
- Evaluate new technologies and methods to make recommendations regarding their use.
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