QC Technical Specialist - Microbiology

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