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Ready to join a workforce UNLIKE any other?

Quality Control Analyst

  • 45002650
  • 907 Floyd Avenue, MCV Main Campus, Virginia, United States, 23284
  • Research
  • Staff
  • School Of Medicine MBU

Advertising Summary: 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.

https://vcujobs.com/why-richmond

Unit: School Of Medicine MBU

Department: Institute for Liver Disease

 

Duties & Responsibilities:

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.

Core Responsibilities:

 Analytical Testing and Laboratory Operations

  • 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.

Quality Control and Data Review

  • 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 escalate findings in accordance with established procedures.
  • Participate in laboratory investigations, root-cause analyses, and development of corrective and preventive actions (CAPAs).

Instrumentation and Laboratory Compliance

  • 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 accordance with institutional requirements and applicable Good Documentation Practices (GDP).

Safety

  • Safely handle radioactive isotopes, chemical reagents, and hazardous laboratory materials in accordance with established radiation safety guidelines and environmental health standards.
  • Where applicable, complete required radiation-safety training and follow procedures governing work with radioactive materials.
  • Consistently utilize appropriate personal protective equipment (PPE)—including monitoring dosimeters, lead shielding, and lab coats—and enforce strict adherence to standard operating procedures (SOPs).
  • Maintain a safe, compliant environment during time-sensitive testing and daily PET/radiotracer production schedules, occasionally accommodating early morning or off-shift operational demands when required.

Qualifications:

Minimum Qualifications

  • Education: Bachelor's degree in Analytical Chemistry, Chemistry, Pharmaceutical Sciences, Biochemistry, or a closely related scientific discipline.
  • Experience: 1–3 years in a cGMP laboratory environment.
  • Demonstrated experience performing analytical chemistry techniques in a GMP or Quality Control Laboratory.
  • Experience with chromatographic and/or spectroscopic analytical methods.
  • Ability to accurately execute established analytical procedures and interpret scientific data.
  • Strong attention to detail and commitment to accurate documentation.
  • Strong written and verbal communication skills.
  • Willingness to work with radioactive materials.
  • Ability to reliably distinguish and evaluate visual characteristics, including color, clarity, opalescence, and visible particulates, when required for QC testing and product release activities, with or without reasonable accommodation.
  • Ability to stand for extended periods, perform precise manual manipulations (pipetting, handling syringes/vials) behind radiation shielding.
  • Ability to lift and carry up to 50lbs of lead-shielded containers and equipment, and wear full PPE (lab coats, lead aprons, gloves, and radiation dosimeters) throughout the shift.
  • Demonstrated ability to work in and foster an environment of respect, professionalism and civility with a population of faculty, staff, and students from all backgrounds and experiences, or a commitment to do so as a staff member at VCU.

Preferred Qualifications

  • Experience working with radioactive materials or within a radiochemistry/radiopharmaceutical laboratory is desirable but not required.
  • Master's degree in Analytical Chemistry, Chemistry, Pharmaceutical Sciences, or a related discipline.
  • Experience with analytical method development, transfer, qualification, or validation.
  • Experience using chromatography data systems (e.g. Waters Empower) for acquisition, processing, review, and documentation of analytical data.
  • Familiarity with FDA regulations, USP standards, ICH guidance, and/or other quality standards applicable to radiochemical laboratories.
  • Experience with electronic laboratory systems, LIMS, or electronic document-management systems.

 

Position will remain open until filled.  Applications received by October 30th, 2026 will be given priority consideration.

This is a restricted position with no set end date and continued employment is dependent upon project need, availability of funding, and performance.

VCU is committed to hiring veterans! VCU will include a veteran's period(s) of military service in the calculation of their annual leave accrual rate. This may provide veterans with an increased leave accrual!

 

Salary Range: $60,000-$75,000

Benefits: All full-time university staff are eligible for VCU’s robust benefits package that includes comprehensive health benefits, paid annual and holiday leave, generous tuition benefits, retirement planning and savings options, tax-deferred annuity and cash match programs, employee discounts, well-being resources, abundant opportunities for career development and advancement, and more.

FLSA Exemption Status: Exempt

Restricted Position: Yes

ORP Eligible: No

Flexible Work Arrangement: On-site

University Job Title: 3323B - Research Analyst Base

 

 

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E-verify Notice: After accepting employment, new hires are required to complete an I-9 form and present documentation of their identity and eligibility to work in the United States. Effective June 1, 2011, agencies in the Commonwealth of Virginia's Executive Branch will use the E-Verify system to confirm identity and work authorization.

If you have questions or need accommodations during the application and interview process, please contact VCU Human Resources at (804) 828-0177 (Voice), (800) 828-1120 (TDD) or askhr@vcu.edu. The HR Welcome Center on the corner of Belvidere Street and W. Franklin Street is open Monday through Friday 8:30 a.m. to 4:30 p.m.