Quality Control Analyst II

Fusion Life Science Technologies LLC; Fort Worth (TX); On-site; USD 55,000 - 85,000; Full time

Job summary

Fusion Life Science Technologies LLC seeks a Quality Control Analyst II in Fort Worth, TX for a 12-month assignment. The role focuses on QC testing, method development, and collaboration with vendors to ensure product quality and regulatory compliance.

Ideal candidates will have experience with capillary electrophoresis, HPLC/GC, and instrument qualification, and will train other analysts while ensuring safety and data integrity in the lab.

Qualifications

• Experience in quality control laboratory settings preferred.
• Familiarity with regulatory documentation and deviation handling.
• Knowledge of basic statistics and data interpretation.

Responsibilities

• Maintain lab cleanliness and safety standards.
• Develop and qualify new testing methods.
• Train analysts in procedures and assays.
• Perform inspections of finished products.
• Coordinate testing with contract labs and vendors.
• Prepare technical reports and deviation documentation.
• Calibrate and maintain lab equipment.
• Review data for regulatory compliance and release decisions.

Skills

Capillary electrophoresis

HPLC/GC

Instrument qualification

Job description

Job Title: Quality Control Analyst II

Location: Fort Worth, TX

Duration: 12 Months

Preferred experience:

• Capillary electrophoresis
• HPLC/GC
• Instrument qualification

Job Description

• 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.
• Supply quality control data necessary for regulatory submissions.
• 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.
• Perform validations or transfers of analytical methods in accordance with applicable policies or guidelines.
• 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.
• Evaluate analytical methods and procedures to determine how they might be improved.
• 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.