Quality Control Analyst

Virginia Commonwealth University; Richmond (VA); Vor Ort; USD 60.000 - 75.000; Vollzeit

Zusammenfassung

Virginia Commonwealth University (VCU) Stravitz-Sanyal Institute seeks a Quality Control Analyst to perform analytical testing in Radiochemistry QC laboratories. You will support development, transfer, qualification, verification, and validation of analytical methods (HPLC/GC), document results per cGMP and FDA guidelines, and assist investigations of OOS results.

The role reports to the Director of Radiochemistry and collaborates with QA, PET/CT staff, and facility leadership to maintain

Qualifikationen

• Bachelor's degree in Analytical Chemistry, Chemistry, Pharmaceutical Sciences, Biochemistry, or a closely related scientific discipline.
• 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.
• Willingness to work with radioactive materials.

Aufgaben

• Perform routine and non-routine analytical testing of materials and samples.
• Support development, transfer, qualification, verification, and validation of analytical methods (including HPLC and GC).
• Evaluate and document test results in accordance with cGMP and regulatory requirements.
• Assist investigations of atypical or out-of-specification results (OOS).
• Maintain laboratory records and supporting documentation with accuracy.
• Ensure testing is completed within established timelines with data integrity.

Kenntnisse

Analytical chemistry

cGMP

Laboratory skills

Ausbildung

Bachelor's degree in Analytical Chemistry, Chemistry, Pharmaceutical Sciences, Biochemistry, or a closely related scientific discipline

Tools

HPLC

GC

LIMS

Waters Empower

Jobbeschreibung

Advertising Summary:

Virginia Commonwealth University (VCU)School of Medicine is a premier academic medical center located inthe heart of Richmond. Accounting for almost half of VCU’ssponsored research, the School of Medicine is internationallyrecognized for patient care and education. Virginia CommonwealthUniversity 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 Universityis seeking a Quality Control Analyst to perform analyticaltesting in its Radiochemistry Quality Control laboratories. Thisposition will perform routine analytical testing and support thedevelopment, implementation and validation of analytical methods,including HPLC and GC; evaluate and document test results inaccordance with cGMP and regulatory requirements; and assist withinvestigations of atypical or out-of-specification (OOS)results.

The Quality Control Analyst ensures that analytical testing,release testing, documentation, and applicable radiation safetypractices are performed in accordance with approved SOPs, USPrequirements, radiation safety guidelines, and applicable FDAregulations. The position reports to the Director of Radiochemistryand works closely with Quality Assurance (QA), PET/CT staff, andfacility leadership to maintain compliant laboratory operations,reliable testing and release processes, and accurate, completedocumentation.

Core Responsibilities:

Analytical Testing and Laboratory Operations

• Perform routine and non-routine analytical testing of rawmaterials, intermediates, finished products, reference standards,and other laboratory samples, as applicable.


• Operate analytical instrumentation such as HPLC, GC, UV-Visspectroscopy, pH meters, balances, and other analytical laboratoryequipment appropriate to assigned testing.


• Perform required visual inspection and appearance testing ofmaterials and finished products, including assessment of color,clarity, opalescence, visible particulates, and other specifiedappearance characteristics.


• Perform calculations, data analysis, and interpretation ofanalytical results.


• Maintain accurate and contemporaneous laboratory records andsupporting documentation.


• Ensure laboratory testing is completed within establishedtimelines while maintaining appropriate standards for accuracy anddata 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 andalignment with approved methods and specifications.


• Identify atypical, out-of-trend (OOT), or out-of-specification(OOS) results and elevate findings in accordance with establishedprocedures.


• 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 equipmentrecords.


• Assist with troubleshooting instrument performance issues andcoordinate service activities when necessary.


• Monitor laboratory reagents, standards, reference materials,and consumables to ensure appropriate storage, labeling, expirationcontrol, and documentation.


• Maintain a clean, organized, and inspection‑ready laboratoryenvironment.


• Draft, revise, and follow SOPs, analytical methods, protocols,worksheets, and other controlled laboratory documents.


• Participate in deviation, CAPA, change-control, andinvestigation processes as appropriate.


• Participate in laboratory quality‑improvement initiatives.


• Maintain documentation in accordance with institutionalrequirements and applicable Good Documentation Practices(GDP).

Safety

• Safely handle radioactive isotopes, chemical reagents, andhazardous laboratory materials in accordance with establishedradiation safety guidelines and environmental healthstandards.


• Where applicable, complete required radiation‑safety trainingand follow procedures governing work with radioactivematerials.


• Consistently utilize appropriate personal protective equipment(PPE)-including monitoring dosimeters, lead shielding, and labcoats and enforce strict adherence to standard operating procedures(SOPs).


• Maintain a safe, compliant environment during time‑sensitivetesting and daily PET/radiotracer production schedules,occasionally accommodating early morning or off‑shift operationaldemands when required.

Qualifications:

Minimum Qualifications

• Education: Bachelor's degree in Analytical Chemistry,Chemistry, Pharmaceutical Sciences, Biochemistry, or a closelyrelated scientific discipline.


• Experience: 1-3 years in a cGMP laboratoryenvironment.


• Demonstrated experience performing analytical chemistrytechniques in a GMP or Quality Control Laboratory.


• Experience with chromatographic and/or spectroscopic analyticalmethods.


• Ability to accurately execute established analytical proceduresand interpret scientific data.


• Strong attention to detail and commitment to accuratedocumentation.


• Strong written and verbal communication skills.


• Willingness to work with radioactive materials.


• Ability to reliably distinguish and evaluate visualcharacteristics, including color, clarity, opalescence, and visibleparticulates, when required for QC testing and product releaseactivities, with or without reasonable accommodation.


• Ability to stand for extended periods, perform precise manualmanipulations (pipetting, handling syringes/vials) behind radiationshielding.


• Ability to lift and carry up to 50lbs of lead‑shieldedcontainers and equipment, and wear full PPE (lab coats, leadaprons, gloves, and radiation dosimeters) throughout theshift.


• Demonstrated ability to work in and foster an environment ofrespect, professionalism and civility with a population of faculty,staff, and students from all backgrounds and experiences, or acommitment to do so as a staff member at VCU.

Preferred Qualifications

• Experience working with radioactive materials or within aradiochemistry/radiopharmaceutical laboratory is desirable but notrequired.


• 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. WatersEmpower) for acquisition, processing, review, and documentation ofanalytical data.


• Familiarity with FDA regulations, USP standards, ICH guidance,and/or other quality standards applicable to radiochemicallaboratories.


• Experience with electronic laboratory systems, LIMS, orelectronic document-management systems.

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

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

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