Senior Quality Assurance Analyst

Top 2 Must Haves:

Method Validation Experience

HPLC Experience

Preferred:

Compendia Experience

Job Description:

• 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 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.