Responsibilities:
- Carry out auditing of study, project, and process reports, records and data; report audit findings to operations via QA audit reports; and determine acceptability of the responses and verify the corrections (includes but not limited to Protocol Audits, Raw Data and Report audits, and Process Audits.
- Interact with internal and external clients to discuss QA observations and study-related issues; and maintain effective and professional working relationships within and across departments in relation to study projects.
- Participate and lead in the improvement initiatives intended to improve quality, compliance of study, project data and reports; effectiveness and efficiency of the processes.
- Detect quality issues and the need for CAPAs and evaluate deviations
- Assist with the preparation for and hosting of client audits and/or regulatory inspections.
- Participate in the preparation, conduct and follow-up for System Audits and Vendor Audits
Qualifications:
- Bachelor’s degree in science, IT, business, or similar
- 2-5 years of quality/laboratory experience
- Excellent oral and written communication skills; ability to build strong client relationships
- Ability to organize and manage multiple priorities
- Excellent time management skills
- Attention to detail, tactful, and diplomatic
- Proficiency in using electronic data and computerized systems.
- Ability to travel, as needed
- Possess a Quality by design mindset, willing to dig deeper by asking questions
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Skills Required
- Bachelor's degree in science, IT, business, or a similar field
- 2-5 years of quality or laboratory experience
- Experience in laboratory and/or GLP/GCP environments
- Excellent oral and written communication skills
- Ability to build strong client relationships
- Ability to organize and manage multiple priorities
- Excellent time management skills
- Attention to detail, tact, and diplomacy
- Proficiency using electronic data and computerized systems
- Ability to travel as needed
- Quality-by-design mindset and willingness to ask questions and investigate deeply
- Must be within commuting distance of Lincoln, Nebraska, for hybrid onsite work
What We Do
Celerion, a leader in early clinical research, delivers Applied Translational Medicine. Celerion applies our expertise and experience to translating information gained in research discoveries, to knowledge of drug action and effect in humans to support early drug development decisions and the clinical pharmacology labeling of new medicines. With over 50 years of experience and 600 global clinic beds (including 24 in-hospital), Celerion conducts and analyzes First-in-Human, clinical proof-of-concept, cardiovascular safety (TQT, robust QT), ADME and NDA-enabling clinical pharmacology studies. Celerion provides expertise on modeling and simulation, study design, medical writing (protocols and reports), clinical data sciences, biostatistics, and PK/PD analysis as well as small and large molecule bioanalytical assays through clinical drug development. Regulatory, drug development and program management complement Celerion’s service offerings. Our operations are strategically located in: Lincoln, Nebraska (Corporate Headquarters) Philadelphia, Pennsylvania Phoenix, Arizona Belfast, Northern Ireland,UK Zurich, Switzerland Vienna, Austria Richmond, Virginia Montreal, Quebec, Canada For more information, visit: www.celerion.com
