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Quality Assurance Engineer

University of Missouri-Columbia
parental leave, paid time off
United States, Missouri, Columbia
801 Conley Avenue (Show on map)
Jan 07, 2025
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 Quality Assurance Engineer position for the University of Missouri Research Reactor Center (MURR) is responsible for assisting the Quality Manager in fulfilling the Quality System needs of the organization. Duties include detail procedure and document review, leadership, teamwork, and guidance of MURR staff on quality programs and training on quality concepts and program requirements. QA Engineers perform internal audits, supplier audits, and facilitate the resolution of deviations and corrective actions. This position requires excellent attention to detail, self-motivation, reliability and ability to cross train for flexibility. Knowledge of a risk based approach and GMP quality system concepts and practices for production, quality control, quality assurance of radiochemical products within the guidelines of the MURR's Quality System must be learned, applied, and demonstrated.

Responsibilities and duties include:

  • QA, QC, Quality, GMP, cGMP, Pharma, Pharmaceutical, FDA, Regulatory, System, Biology, Chemistry, Specialist, Assurance, Compliance
  • Drafting and reviewing standard operating procedures, production batch records, analytical methods, analytical protocols, and equipment qualification protocols.
  • Coordinating the program elements of the MURR Quality Systems per FDA GMP guidelines and demonstrating compliance during audits.
  • Product labeling review and batch release of radioisotopes produced under the MURR Quality System.
  • Internal audits and continuous improvement efforts for programs, systems, and results to ensure compliance with procedures and regulations.
  • Conducting supplier audits to ensure approved materials, suppliers and purchased items continue to meet MURR specifications and product requirements.
  • Facilitation of deviation, CAP, change control, and document control programs and review of related reports with subject matter experts and management to ensure effective corrective actions are implemented with the effectiveness verified.
  • Presentation of in-house training for GMP, GLP, and quality program procedures and concepts to new employees (including student workers) and refresher training existing staff.
  • Support and assistance of QA Engineer Peers, Production Staff, and Quality Control Staff in daily activities and endeavors to fulfill customer and MURR GMP requirements.
  • Cross-training for flexibility in supporting the daily, weekly and monthly Quality System needs along with the QA Engineering Team, and Quality Manager.
  • To be successful, the QA Engineer will develop, lead by example, and demonstrate the following qualities and skill sets: Excellent attention to detail, teamwork, interpersonal and written communication skills, constructive facilitation of issue resolution, such as for deviation and caps, program knowledge for leadership and guidance of other groups, new peers in training, risk assessment and management concepts, root cause linked corrective actions, leading group meetings and training presentations for the quality system, excellent judgement on when to involve peers and the Quality Manager on questions, issues and for guidance, and viewed within the organization as reliable resource and go to person for quality system and quality assurance questions and assistance.
Shift

Monday-Friday, 07:30 - 4:30pm w/ occasional evenings and weekends, to be discussed in interview.

Minimum Qualifications

A Bachelor's degree in related/ relevant area and at least 3 years of experience from which comparable knowledge and skills can be acquired is necessary. Additional licensures are necessary as required by regulatory authorities.

Preferred Qualifications

3-5 Years in a pharmaceutical cGMP environment

Anticipated Hiring Range

Salary Range: $55,000 - $65,000 per year
Grade: GGS MKT
University Title: Reactor Engineer
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.

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