Quality Assurance Engineer

MRR Quality Control & Assurance.

The University of Missouri Research Reactor (MURR) is seeking a Quality Assurance Engineer This position will report to the Quality Assurance Manager and will be responsible for supporting the MURR quality system, maintaining cGMP compliance, performing quality assurance reviews of radiopharmaceutical production records and supporting documentation, and ensuring product quality and regulatory compliance throughout production and release activities.
The Quality Assurance Engineer provides quality oversight and support for radiopharmaceutical manufacturing, testing, and release activities. This role is responsible for reviewing GMP documentation, supporting quality systems, monitoring production activities, ensuring adherence to regulatory requirements, and assisting with continuous improvement initiatives. The individual will work closely with production, quality control, and support personnel to ensure compliance with current Good Manufacturing Practices (cGMP), applicable procedures, and MURR quality standards.

Key Duties Performed by This Position Will Include
* Complete training on the MURR Quality System, GMP compliance program, radiopharmaceutical production processes, and associated procedures.
* Access, review, interpret, and apply quality system procedures, forms, and supporting documentation requirements.
* Maintain compliance with cGMP documentation standards and ALCOA data integrity principles.
* Observe and support production, quality control, and quality assurance activities as part of qualification and development requirements.
* Review and approve controlled material release packages, including certificates of analysis, material documentation, labeling verification, and inventory records.
* Review microbiology records, including media qualifications, aseptic gowning qualifications, environmental monitoring activities, and bioburden testing documentation.
* Conduct quality assurance reviews of production batch records, supporting calculations, labeling, logs, and release documentation.
* Review quality control testing records and supporting documentation to verify compliance with specifications and procedures.
* Provide on-the-floor quality support during radiopharmaceutical processing activities.
* Review quality system records, including deviations, investigations, corrective actions, and related quality events.
* Support calibration, preventive maintenance, requalification activities, and associated documentation reviews for GMP equipment.
* Participate in department meetings, training programs, and continuous improvement initiatives.
* Serve as a quality resource by providing guidance on procedures, documentation requirements, and quality system expectations.
* Lead and support continuous improvement initiatives by applying engineering principles to identify process improvement opportunities, investigate manufacturing trends, perform root cause analysis, and implement sustainable solutions that enhance product quality, process performance, and GMP compliance.
* Must be available for reliable and consistent onsite work.

In Addition, The Individual Will
* Maintain a strong commitment to safety and radiation protection principles, including adherence to ALARA requirements.
* Properly utilize personal protective equipment (PPE), dosimetry devices, and applicable safety controls.
* Demonstrate knowledge of radiation safety procedures and emergency response requirements.
* Promote a culture of quality, compliance, safety, and continuous improvement throughout the organization.
* Develop proficiency in interpreting GMP requirements and applying quality standards independently with minimal supervision.
* Collaborate effectively with production, quality control, regulatory, and operational personnel to ensure timely product release and compliance with established quality requirements.

Monday - Friday, 7:30 - 4:30pm w/ occasional evenings and weekends, to be discussed in interview.

Bachelor's degree in related/relevant area and at least 4 years of experience from which comparable knowledge and skills can be acquired is necessary.

3-5 Years in a pharmaceutical cGMP environment.

Salary Range: $55,000 - $92,000 per year

Grade: GGS M09

University Title: Quality Assurance Engineer II

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

Employment visa sponsorship is not available for this position.

MU 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

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 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!

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/departments-staff/human-resources/benefits-retirement

Equal Employment Opportunity

The University of Missouri is an Equal Opportunity Employer.

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