QC Analyst

2 weeks ago


Fort Worth, United States Source One Technical Solutions Full time

Seeking a QC Analyst with Method Validation and HPLC experience for a consulting position at a pharmaceutical client in Fort Worth, TX 76134.


Qualifications:

• Bachelor's in Biology, Microbiology, Chemistry, Biochemistry or similar Scientific major.

• Method Validation Experience

• HPLC Experience


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.

• 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.

• 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.

• 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.


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