Quality Control Analyst II

Quality Control Analyst II

Job Location - Fort Worth, TX Duration - 12 months

Preferred Experience:

• Capillary electrophoresis
• HPLC
• Instrument qualification

Responsibilities:

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 the 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.