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
