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Quality Assurance Specialist / Quality Assurance Engineer New

305c6eeb6a1e

University of Missouri

Negotiable

Columbia, United States

United States

Other

ASAP

04/05/2021

03/06/2021

Not specified

Permanent | Full Time

Job Title: Quality Assurance Specialist / Quality Assurance Engineer Location: Columbia Full/Part Time: Full-Time Job ID: 36029 Hiring Department MU Research ReactorJob 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. Salary Hiring Range: $45,000 - $60,000GGS Grade: MKTUniversity Title: Reactor EngineerInternal applicants can determine their university title by accessing the Talent Profile tile in myHR.Shift This position is currently scheduled M-F, 8-5, with occasional evening and weekend work required. This position is part of a work team that is expected to begin some weekend work on a rotating basis that could include one or both weekend days and evenings or early or late hours as needed.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 necessaryAdditional licensures are necessary as required by regulatory authoritiesPreferred Qualifications A Bachelor’s degree in a science-related field and at least 3 years of experience in an FDA regulated or GMP related work environment.Additional licensures are necessary as required by regulatory authorities.Benefit Eligibility This position is eligible for University benefits. The University offers a comprehensive benefits package, including medical, dental and vision plans, retirement, paid time off, and educational fee discounts. For additional information on University benefits, please visit the Faculty & Staff Benefits website at [http://www.umsystem.edu/totalrewards/benefits](http://www.umsystem.edu/totalrewards/benefits)*Diversity Commitment*The University of Missouri is fully committed to achieving the goal of a perse and inclusive academic community of faculty, staff and students. We seek inpiduals who are committed to this goal and our core campus values of respect, responsibility, discovery and excellence.*Equal Employment Opportunity*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, protected veteran status, or any other status protected by applicable state or federal law. This policy shall not be interpreted in such a manner as to violate the legal rights of religious organizations or the recruiting rights of military organizations associated with the Armed Forces or the Department of Homeland Security of the United States of America. For more information, call the Vice Chancellor of Human Resource Services/Affirmative Action officer at 573-882-4256.To request ADA accommodations, please call the Disability Inclusion and ADA Compliance Manager at 573-884-7278.*EEO IS THE LAW*To read more about Equal Employment Opportunity (EEO) please use the following links:* EEO is the Law [English Version](http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf)* EEO is the Law [Spanish Version](http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeosp.pdf)* EEO is the Law [Chinese Version](http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost(chinese).pdf)



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