Change Control Specialist

Columbia, Missouri


Employer: University of Missouri
Industry: Research
Salary: $65000 - $90000 per year
Job type: Full-Time

Hiring Department

Research Reactor

A life-saving operation in the middle of America - the University of Missouri Research Reactor (MURR) - needs you to help guide its future. MURR is expanding its critical cancer-fighting and medical isotope production.

MURR's reactor is the highest-power university research reactor in the United States, operating at 10 megawatts, 6.5 days a week and 52 weeks a year. The MURR facility enables research across many disciplines - From investigating ancient cultures and how plants respond to their environment, to analyzing industrial materials and developing radiopharmaceuticals that have lifesaving clinical applications. The MURR facility is a reliable resource for researchers, scientists, engineers and students across the country.

Be a part of the future of fighting cancer and saving lives.

Be a part of MURR

Job Description

The University of Missouri Research Reactor (MURR) is seeking a Change Control Specialist. This position will report to the Change Control and Translation Manager within the Innovative Development & Translation (ID&T) division.

The Innovative Development & Translation (ID&T) division at MURR focuses on advancing radioisotope production methodologies with an emphasis on their translatability into current Good Manufacturing Practice (cGMP) standards. The division pursues three main goals: first, the development of novel radioisotope production techniques that can be scaled up to meet industry needs and be aligned with cGMP requirements; second, addressing and resolving challenges within existing isotope production lines at MURR; and third, providing essential support to various research groups within MURR as needed. Through these objectives, the ID&T division aims to contribute to cutting-edge advancements in research and radioisotope production, ensuring both innovation and adherence to regulatory standards within the research reactor environment.

The purpose of this position is to provide change management support to GMP groups at MURR (production, QC, etc). As well as ensuring compliance in accordance with cGMPs, FDA regulations, and MURR policies/procedures.

Key Duties Performed by This Position Will Include
  • Draft/Review/Manage change controls and associated activities.
  • Manage timelines to ensure projects meet necessary deadlines and take appropriate actions as needed if not.
  • Provide routine updates and project status reports.
  • Collaborate with other groups (production, QC, QA, RA) to implement process changes/improvements and maintain compliance.
  • Observe manufacturing activities to support implementation of best practices and improvements.
  • Coordination/tracking/communication of all process changes.
  • Perform risk assessments to identify potential risks associated with proposed changes and implement measures to mitigate them.
  • Draft and aid in executing experimental plans, ensuring that experiments are conducted accurately, efficiently, and in adherence to established protocols and safety standards.
  • Ensure compliance with all safety protocols and regulations related to radioisotope handling and production
  • Stay updated and informed on cGMP regulations and guidelines for radiopharmaceutical manufacturing.

Successful candidates will be persuasive communicators with exceptional organizational and time management skills. They must demonstrate the following durable skills: leadership, character, collaboration, communication, creativity, critical thinking, mindfulness, growth mindset, and fortitude. Additionally, these individuals should display good customer service, confidentiality, integrity, and a commitment the University of Missouri's values of respect, responsibility, discovery and excellence.

Shift

Monday - Friday 8:00 a.m. - 5:00 p.m.

Minimum Qualifications

A Bachelor's degree and at least 3 years of experience from which comparable knowledge and skills can be acquired is necessary

Preferred Qualifications
  • Prior experience working in a nuclear-related field is preferred.
  • Advanced experience in current Good Manufacturing Practices (cGMP) is preferred.
  • Proven experience in radioisotope manufacturing and associated methods.
  • Strong understanding of nuclear reactions and radiation safety.
  • Experience working with research reactors is highly desirable.
  • Ability to work collaboratively in a multidisciplinary research environment.
  • Effective communication skills, both written and verbal.
  • Demonstrated commitment to safety in a laboratory setting.


Anticipated Hiring Range

Salary Range: $65,000 to $90,000

Grade: GGS-010

University Title: Research Specialist Lead

Internal applicants can determine their University title by accessing the Talent Profile tile in myHR.

Community Information

Columbia offers small-town friendliness with big city features and a high quality of life for people of all ages and interests. Founded on education and known as an ideal college town, its location also makes it an attractive spot for businesses and travelers. Located on Interstate 70 and U.S. Highway 63, Columbia is right in the middle of the state and the nation. Just a couple hours' drive from St. Louis and Kansas City, Columbia is Boone County's largest population center offering big-city culture, activities, and resources with a low cost of living. Columbia is home to a variety of restaurants and entertainment venues and hosts more than a dozen cultural festivals each year. If you want to grow your career, continue your education, raise a family, and retire, Columbia is a good place to be!

Benefit Eligibility

This position is eligible for University benefits. As part of your total compensation, the University offers a comprehensive benefits package, including medical, dental and vision plans, retirement, paid time off, short- and long-term disability, paid parental leave, paid caregiver leave, and educational fee discounts for all four UM System campuses. For additional information on University benefits, please visit the Faculty & Staff Benefits website at https://www.umsystem.edu/totalrewards/benefits .

Values Commitment

We value the uniqueness of every individual and strive to ensure each person's success. Contributions from individuals with diverse backgrounds, experiences and perspectives promote intellectual pluralism and enable us to achieve the excellence that we seek in learning, research and engagement. This commitment makes our university a better place to work, learn and innovate.

In your application materials, please discuss your experiences and expertise that support these values and enrich our missions of teaching, research, and engagement.

Equal Employment Opportunity

The University of Missouri System is an Equal Opportunity Employer. Equal Opportunity is and shall be provided for all employees and applicants for employment on the basis of their demonstrated ability and competence without unlawful discrimination on the basis of their race, color, national origin, ancestry, religion, sex, pregnancy, sexual orientation, gender identity, gender expression, age, disability, or protected veteran status, or any other status protected by applicable state or federal law. This policy applies to all employment decisions including, but not limited to, recruiting, hiring, training, promotions, pay practices, benefits, disciplinary actions and terminations. For more information, visit https://www.umsystem.edu/ums/hr/eeo or call the Director of Employee and Labor Relations at 573-882-2146.

To request ADA accommodations, please call the Director of Accessibility and ADA at 573-884-7278.

Created: 2024-08-30
Reference: 51851
Country: United States
State: Missouri
City: Columbia
ZIP: 65202


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