Quality Control Analyst II BioPharma Consulting JAD Group Fort Worth, TX Job Details Contract 6 hours ago Qualifications Content creation for technical audiences Defect resolution root cause analysis Laboratory equipment performance testing and validation Standard Operating Procedures (SOPs) implementation Laboratory instruction Laboratory instrument validation Technical writing experience within manufacturing Equipment troubleshooting Good documentation practices (GDP) Laboratory equipment calibration Assay development Laboratory reports Laboratory equipment repair Bachelor's degree Quality assurance standard operating procedures Scientific protocols Laboratory standard operating procedures Compliance documentation Laboratory preventive maintenance Verification of laboratory test methods Technical skills instruction Technical troubleshooting support Quality control communication Regulatory compliance analysis Cross-functional collaboration Test validation method Standard operating procedures (SOPs) Cross-functional communication Failure analysis Scientific reports Full Job Description 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 Benefits Contract position: 12 months, with possible extension

Shift:

Administrative shift

Days:

Monday to Friday, 40 hours/week On-site in Fort Worth, Texas