Manager - Quality Assurance

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
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