Quality Control Analyst

Virginia Commonwealth University (VCU) School of Medicine is a premier academic medical center located in the heart of Richmond. Accounting for almost half of VCU’s sponsored research, the School of Medicine is internationally recognized for patient care and education. Virginia Commonwealth University is an equal opportunity employer.

School Of Medicine MBU

Institute for Liver Disease

The Stravitz-Sanyal Institute at Virginia Commonwealth University is seeking a Quality Control Analyst to perform analytical testing in its Radiochemistry Quality Control laboratories. This position will perform routine analytical testing and support the development, implementation and validation of analytical methods, including HPLC and GC; evaluate and document test results in accordance with cGMP and regulatory requirements; and assist with investigations of atypical or out-of-specification (OOS) results.

The Quality Control Analyst ensures that analytical testing, release testing, documentation, and applicable radiation safety practices are performed in accordance with approved SOPs, USP requirements, radiation safety guidelines, and applicable FDA regulations. The position reports to the Director of Radiochemistry and works closely with Quality Assurance (QA), PET/CT staff, and facility leadership to maintain compliant laboratory operations, reliable testing and release processes, and accurate, complete documentation.

• Perform routine and non-routine analytical testing of raw materials, intermediates, finished products, reference standards, and other laboratory samples, as applicable.
• Operate analytical instrumentation such as HPLC, GC, UV-Vis spectroscopy, pH meters, balances, and other analytical laboratory equipment appropriate to assigned testing.
• Perform required visual inspection and appearance testing of materials and finished products, including assessment of color, clarity, opalescence, visible particulates, and other specified appearance characteristics.
• Perform calculations, data analysis, and interpretation of analytical results.
• Maintain accurate and contemporaneous laboratory records and supporting documentation.
• Ensure laboratory testing is completed within established timelines while maintaining appropriate standards for accuracy and data integrity.
• Support the development, transfer, qualification, verification, and/or validation of analytical methods.

• Review analytical data for GDP (ALCOA+) compliance and alignment with approved methods and specifications.
• Identify atypical, out-of-trend (OOT), or out-of-specification (OOS) results and elevate findings in accordance with established procedures.
• Participate in laboratory investigations, root-cause analyses, and development of corrective and preventive actions (CAPAs).

• Perform or coordinate routine instrument calibration, qualification, maintenance, and performance checks.
• Maintain appropriate instrument logs and equipment records.
• Assist with troubleshooting instrument performance issues and coordinate service activities when necessary.
• Monitor laboratory reagents, standards, reference materials, and consumables to ensure appropriate storage, labeling, expiration control, and documentation.
• Maintain a clean, organized, and inspection-ready laboratory environment.
• Draft, revise, and follow SOPs, analytical methods, protocols, worksheets, and other controlled laboratory documents.
• Participate in deviation, CAPA, change-control, and investigation processes as appropriate.
• Participate in laboratory quality-improvement initiatives.
• Maintain documentation in…