Quality Control Analyst II

Fusion Life Science Technologies • Fort Worth, TX

22h • Onsite

About The Position

This role is responsible for ensuring that lab cleanliness and safety standards are maintained. The analyst will develop and qualify new testing methods, train other analysts, and perform visual inspections of finished products. Participation in internal assessments and audits, and troubleshooting equipment problems are also key responsibilities. The role involves evaluating new technologies, serving as a technical liaison, and coordinating testing with contract laboratories. Writing technical reports, standard operating procedures, and supplying quality control data for regulatory submissions are essential duties. The analyst will also receive and inspect raw materials, review data from contract laboratories, and prepare method transfer documentation. Method validations and transfers, participation in out-of-specification investigations, and monitoring testing procedures are critical. Investigating questionable test results, interpreting test results, and identifying quality problems are also part of the role. Finally, the analyst will complete documentation, calibrate and maintain equipment, compile laboratory test data, and conduct routine and non-routine analyses.

Requirements

• Capillary electrophoresis
• HPLC/GC Instrument qualification

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.
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: No Education Listed