Quality Assurance Engineer

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.