Quality Assurance Specialist - Radiology

Position Summary
Position is responsible for implementing, coordinating and performing quality assurance activities to ensure compliance with applicable standard procedures and regulations.

Job Description

Primary Duties & Responsibilities

• Prepare technical documents (SOPs, master batch records, specifications, validation protocol, reports, and others) for assigned projects.
• Responsible for coordinating and/or performing quality assurance activities to be complaint with applicable SOPs and federal and local regulations.
• Assist Quality Assurance Manager with any regulatory document preparation.
• Conduct quality investigations to determine the root causes.
• Assist Quality Assurance Manager in preparing and responding to external audits.
• Coordinates annual or periodic quality control testing with facility coordinator, and follows up the completion of the tests.
• Serve as a resource for faculty and staff regarding interpretation of federal regulations governing human subject research, along with policies, procedures and practices pertaining to human studies.
• Identify workflow processes for inefficiencies and develop strategies for improvement.
• Provide back-up and support for co-workers on an as needed basis.
• Participate in continuing education in the field of human subject research.
• Attend conferences or other educational meetings as appropriate.
• Special projects as assigned.

Working Conditions

Job Location/Working Conditions
Physical Effort

• Typically sitting at desk or table.
• Repetitive wrist, hand or finger movement.

Equipment

• Office equipment.

Preferred Qualifications

• Bachelor's degree in life science or equivalent work experience in Quality Assurance.
• A minimum of two years of experience in Quality Assurance​.
• Previous work experience in the radiopharmaceutical production.
• Understanding of federal and local regulations applicable for radiopharmaceutical production and pharmacy operation.
• Effective verbal, written and interpersonal communication skills.
• Demonstrated Microsoft office suite abilities.
• Familiarity with project management.
• Attention to details.
• Ability to work in a team environment.
• Ability to initiate actions and solve problems using sound judgment.
• Demonstrated detailed knowledge of federal, state, local regulations and in-depth understanding of ethical principles regarding the conduct of research and regulatory issues involving protection of human subjects in research.
• Ability to problem solve within the framework of federal regulations, laws and guidance pertaining to human subject protections, including 45CFR46, 21CFR50,56, HIPAA, Good Clinical Practice, the Declaration of Helsinki and the Belmont Report and the HRPO Policies and procedures.
• Ability to manage multiple projects at once with a high level of accuracy and attention to detail.
• Critical review and auditing skills.
• Ability to work independently to meet stated objectives with minimal supervision.
• Demonstrate excellent interpersonal, analytic and leadership skills.
• Knowledge of the scientific research process in both biomedical and behavioral fields.
• Strong conceptual and critical thinking skills with the ability to apply knowledge to a variety of situations.
• Ability to exercise creativity in solving problems effectively while employing good judgment.
• Excellent communication skills ¾ written and oral, including public speaking.
• Cooperative and positive attitude including demonstrated team building skills.
• Accepts and adapts to changes in office procedures or priorities.
• Skilled in working in an all-electronic environment including expertise with Microsoft Office.
• Experience developing and/or implementing Corrective Action Preventive Action (CAPA) plans in relation to patient safety, research compliance and quality assurance monitoring.

Required Qualifications

• Bachelor’s degree or equivalent combination of education and experience.
• Experience with quality assurance monitoring.
• Three to five years relevant experience in administration of IRB and/or clinical trials or research administration is required.
• Successful applicant will be expected to obtain CIP upon meeting eligibility requirements.

Grade
G12

Salary Range
$57,300.00 - $97,700.00 / Annually

The salary range reflects base salaries paid for positions in a given job grade across the University. Individual rates within the range will be determined by factors including one's qualifications and performance, equity with others in the department, market rates for positions within the same grade and department budget.

Questions

For frequently asked questions about the application process, please refer to our External Applicant FAQ .

Accommodation

If you are unable to use our online application system and would like an accommodation, please email [email protected]  or call the dedicated accommodation inquiry number at 314-935-1149 and leave a voicemail with the nature of your request.

Pre-Employment Screening
All external candidates receiving an offer for employment will be required to submit to pre-employment screening for this position. The screenings will include criminal background check and, as applicable for the position, other background checks, drug screen, an employment and education or licensure/certification verification, physical examination, certain vaccinations and/or governmental registry checks. All offers are contingent upon successful completion of required screening.

Benefits Statement

Personal

• Up to 22 days of vacation, 10 recognized holidays, and sick time.

• Competitive health insurance packages with priority appointments and lower copays/coinsurance.

• Want to Live Near Your Work and/or improve your commute? Take advantage of our free Metro transit U-Pass for eligible employees. We also offer a forgivable home loan of up to $12,500 for closing costs and a down payment for homes in eligible neighborhoods.

• WashU provides eligible employees with a defined contribution (403(b)) Retirement Savings Plan, which combines employee contributions and university contributions starting at 7%.

Wellness

• Wellness challenges, annual health screenings, mental health resources, mindfulness programs and courses, employee assistance program (EAP), financial resources, access to dietitians, and more!

Family

• We offer 4 weeks of caregiver leave to bond with your new child. Family care resources are also available for your continued childcare needs. Need adult care? We’ve got you covered.

• WashU covers the cost of tuition for you and your family, including dependent undergraduate-level college tuition up to 100% at WashU and 40% elsewhere after seven years with us.

For policies, detailed benefits, and eligibility, please visit: https://hr.wustl.edu/benefits/

EEO/AA Statement
Washington University in St. Louis is committed to the principles and practices of equal employment opportunity and especially encourages applications by those from underrepresented groups. It is the University’s policy to provide equal opportunity and access to persons in all job titles without regard to race, ethnicity, color, national origin, age, religion, sex, sexual orientation, gender identity or expression, disability, protected veteran status, or genetic information.

Diversity Statement
Washington University is dedicated to building a diverse community of individuals who are committed to contributing to an inclusive environment – fostering respect for all and welcoming individuals from diverse backgrounds, experiences and perspectives. Individuals with a commitment to these values are encouraged to apply.