Manager - Quality Assurance

Job ID59482 Location Columbia Full/Part TimeFull-Time Hiring Department MRR Quality Control & Assurance Job Description At the University of Missouri Research Reactor (MURR) we are currently recruiting an exceptional individual with a passion for science and desire to seek excellence in a dynamic, stimulating environment. As the Manager - Quality Assurance you will evaluate the compliance of Production and Laboratory documents such as batch records, noncompliance records, and release documentation/data. A successful candidate will have a strong attention to detail, comprehensive and creative problem-solving skills, and leadership skills. Join us in our pursuit to produce innovative, world-class radiopharmaceuticals that positively impact patients' lives worldwide. Key Duties Performed by This Position Will Include The Manager - Quality Assurance reports directly to the Associate Director - Quality at MURR and will lead the QA team focusing on production and laboratory execution oversight and guidance for the GMP organization. Deliver efficient and effective outcomes in the areas of GMP quality and compliance to ensure the continued successfulness of the Research Reactor GMP Program. Responsibilities include, not limited to:

• Lead the QA Engineer team which includes training, coaching, and offering performance and development management. Provide support and assistance for GMP personnel in daily activities to fulfill customer and GMP requirements.
• Perform batch release activities of the radioisotopes produced.
• Draft and/or review standard operating procedures, production batch records, analytical chemistry and microbiology methods, analytical protocols, and equipment qualification protocols.
• Draft and/or review records such as deviations, CAPAs, change controls, and document control records with subject matter experts and management.
• Identify, execute, and drive efficiency/compliance improvement projects within the GMP program, and encourage the QA team members to do the same.
• Maintain awareness of current regulatory expectations and industry standards to ensure lab and production practices remain current. Participate in internal audits, vendor audits, client audits, and regulatory inspections as required.
• Apply constructive issue resolution, root cause analysis, risk assessment/decision making, and creative problem solving.
• All other duties as assigned. Shift Monday-Friday, 8:00am - 5:00pm (flexible) w/ occasional evenings and weekends, to be discussed in interview. Minimum Qualifications Bachelor's degree or equivalent combination of education and experience and at least 5 years of experience from which comparable knowledge and skills can be acquired is necessary. Preferred Qualifications
• Preference will be given to those with management experience, cGMP experience, general laboratory experience, and/or regulated manufacturing experience.
• Experience with technical writing, root cause analysis, effective corrective/preventative action identification, and/or risk assessments.

Anticipated Hiring Range

Salary Range:

$90,000-$135,000/yr

Grade:

GGS-M13

University Title:

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