QC Technical Specialist - Microbiology

QC Technical Specialist - Microbiology Columbia, MO Job Details Full-time $70,000 - $100,000 a year 2 days ago Benefits Paid parental leave Caregiver leave Disability insurance Health insurance Dental insurance Paid time off Parental leave Vision insurance Qualifications Strategic management Document review (document control) Microbiology Customer service Technical documentation ISO standards Regulatory compliance Compliance audits & assessments Laboratory experience Process improvement Data reporting GMP Technical report writing Master's degree Laboratory regulatory affairs Scientific protocols Decision making Laboratory quality control Mentoring Quality standards in production Cleanroom Microbiological analysis Data collection Training & development Root cause analysis Senior level Training Cross-functional collaboration Project leadership Cross-functional team management Leadership 2 years Regulatory compliance management Time management Full Job Description Hiring Department MRR Quality Control & Assur Job Description The University of Missouri Research Reactor (MURR) is seeking a Quality Control Technical Specialist reporting to the QC Manager. The candidate will apply technical, business, and industry knowledge to provide scientific consultation to the department. Actively contributes to the strategic direction of the department based on regulatory knowledge and industry best practices. Assignments may be broad in nature, requiring originality and ingenuity. Has appreciable latitude for unreviewed action or decision. Key Duties Performed by This Position Will Include Performs supportive functions for the QC organization with an emphasis on microbiology and GMP cleanroom practices. May include, not limited to: investigation/deviation support, data trending activities, data gathering for annual data reports, periodic specification/method reviews, assisting with compendial review, assisting with client/regulatory audits, and leading client/regulatory observation resolution. Ensure all environmental monitoring activities and cleanroom hygiene practices comply with current GMP regulations for ISO 5 through 8 environments. Manages QC related microbiology investigations and/or deviations independently. Author technical documents such as protocols, methods, summary reports, instrument qualifications, or procedures independently. Evaluate and assess impact of proposed changes to controlled documents and/or project scope. Develop new microbiology procedures of moderate and advanced complexity to meet changing regulatory expectations. Performs high level laboratory activities and potentially site-wide compliance activities to address/remediate emerging compendial and regulatory initiatives. Develop/validate methods of moderate and advanced complexity. Perform peer review of routine and complex laboratory documentation. Review technical documents for accuracy, thoroughness, and regulatory compliance. Able to identify larger quality/compliance gaps within the department and remediate with guidance. Train, coach, or mentor others on technical material, personal development, business matters, and/or compliance topics. Lead improvement initiatives both individual projects and small cross functional team-driven projects. Apply constructive issue resolution, root cause analysis, risk assessment/decision making, and creative problem solving. Work to build consensus. Successful candidates will be persuasive communicators with exceptional organizational and time management skills. They must demonstrate the following durable skills: leadership, character, collaboration, communication, creativity, critical thinking, metacognition, mindfulness, growth mindset, and fortitude. Additionally, customer service, confidentiality, integrity, and a commitment university values in their activities. Shift Monday through Friday, 8AM to 5PM with occasional after-hours support Minimum Qualifications Master's degree in related/relevant area and at least 2 years of experience from which comparable knowledge and skills can be acquired is necessary. Preferred Qualifications Preference will be given to those with cGMP experience, and specifically those with microbiology and/or cleanroom expertise. Anticipated Hiring Range $70,000 to $100,000

Salary Range:

$70,000 to $100,000 per year

Grade:

GGS M13

University Title:

QUALITY CONTROL TECHNICAL SPECIALIST

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 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. Equal Employment Opportunity The University of Missouri is an Equal Opportunity Employer. To request ADA accommodations, please call the Director of Accessibility and ADA at 573-884-7278.