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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
