Job Details
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.