About this role
We are seeking a Quality Control Analyst II to support laboratory testing, method development and quality operations at a manufacturing site in Fort Worth, Texas. Key Responsibilities Conduct routine and non-routine analyses of in-process materials, raw materials, environmental samples, finished goods and stability samples. Develop and qualify new testing methods; perform validations or transfers of analytical methods per applicable policies and guidelines.
Prepare or review method transfer documentation, including technical transfer protocols and reports. Interpret test results against specifications and control limits and recommend whether data is appropriate for release. Participate in out-of-specification (OOS) and failure investigations and recommend corrective actions; investigate or report questionable results.
Write technical reports and documentation such as deviation reports, testing protocols and trend analyses; write or revise QC standard operating procedures. Calibrate, validate and maintain laboratory equipment; identify and troubleshoot equipment problems. Receive and inspect raw materials and perform visual inspections of finished products.
Coordinate testing with contract laboratories and vendors, and review their data for accuracy and regulatory compliance. Supply QC data for regulatory submissions and participate in internal assessments and audits. Serve as technical liaison between Quality Control and other departments, vendors or contractors.
Train other analysts on laboratory procedures and assays; ensure lab cleanliness and safety standards are maintained. Evaluate new technologies and methods and recommend improvements to analytical procedures.
Education Bachelor's degree in Chemistry, Biochemistry, Biology or a related scientific field Preferred Experience Capillary electrophoresis HPLC/GC Analytical instrument qualification Key Skills Analytical method development, qualification, validation and transfer OOS/deviation investigations and root cause analysis Technical writing: protocols, reports, SOPs and trend analyses Laboratory equipment calibration, maintenance and troubleshooting Knowledge of GMP/GDP and regulatory compliance in a quality control laboratory Ability to train others and work cross-functionally with vendors and contract laboratories
Contract position: 12 months, with possible extension Shift: Administrative shift Days: Monday to Friday, 40 hours/week On-site in Fort Worth, Texas