Senior QA Specialist Radiopharmaceutical - Radiology

Scheduled Hours

40

Position Summary

Leads and manages day-to-day operations for quality initiatives for the Cyclotron Facility and Nuclear Pharmacy. Coordinates planned, systematic approaches to identify, design measure, prioritize, and monitor quality initiatives and achievement of outcomes for Cyclotron Facility and Nuclear Pharmacy. Establishes and implements performance improvement methodologies designed to increase operational and pharmaceutical production services and decrease opportunities for error. Develop a quality improvement culture with staff and leaders to support organizational change and development. Oversee education, including onboarding, annual competencies and presentations for staff. The Cyclotron Facility and Nuclear Pharmacy provides PET isotopes, radiochemical, radiotracers and radiopharmaceuticals to the research and medical communities for use in research and clinical practice. The Cyclotron Facility and Nuclear Pharmacy continues to be one of the leading academic facilities for PET radiopharmaceutical production, routinely producing more than 40 different kinds of radiopharmaceuticals.

Job Description

Primary Duties & Responsibilities

Quality Assurance Development

• Provides a systematic approach to quality initiatives.
• Designs and executes quality plans to improve quality system in the group.
• Provides leadership and hands-on participation in projects to develop quality improvement skills.
• Educates organizational members and project participants on quality improvement methodologies and tools.
• Leads facility-wide initiatives that align with performance improvement plans.

Quality Assurance Oversight

• Supports facility directors to promote the operations with the quality systems integrated.
• Communicates quality plans to assure integration with operations and evaluate effectiveness of plans.
• Reviews of data and technical documents.

Regulatory Filings/Reports/Training/Oversight

• Evaluates new national standards, regulations, and legislations and promotes group’s understanding of impact and improvement.
• Provides coaching/mentoring for projects in quality improvement.
• Manages process for review of quality issues arising from adverse events or near misses in the department.
• Oversees development of educational opportunities including new employee onboarding and annual competencies.
• Oversees ongoing data collection and analysis processes and reporting.
• Oversees personnel training program.

Document Management

• Uses information systems to provide reports.

User Outreach and Administration

• Represents the facility to appropriate internal and external groups
• Provides effective day-to-day management and administration for designated program.
• Serves as a liaison with university researchers and industry partners for collaboration work.
• Performs other duties as assigned.

Preferred Qualifications

• Previous work experience in the pharmaceutical field.
• 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.

Required Qualifications

Bachelor's degree in sciences with at least ten years of QA experience, or Master’s or higher degree with at least five years of QA experience in a pharmaceutical manufacturing field.

Grade

C14

Salary Range

$73,400.00 - $113,800.00 / 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 CandidateQuestions@wustl.edu or call the dedicated accommodation inquiry number at 314-935-1149 and leave a voicemail with the nature of your request.

Pre-Employment Screening

Al