Quality Control Analyst II

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.

Requirements

• 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