Perform and document all procedures, materials and results in compliance with applicable regulatory standards as applicable (protocols, methods, SOPs, etc.)
Embody the behaviors and performance characteristics as described in our core values
Develop knowledge of regulatory requirements (GLP, GCP, GMP, EPA, OECD, CLIA, 21CFR Part 11) and apply as required by operational area
Develops effective communication skills through both informal and formal discussions with peers, supervisor, internal teams, and externally with Regulators
Develop critical thinking, troubleshooting and time management skills aligned with the needs of the operational area
Ensures that operational area is clean and inspection ready at all times
Accurately prepare reagents with oversight
Accurately perform laboratory support functions such as labeling, monitoring expiration dates, waste removal and solution preparation with oversight
Operate and maintain analytical instruments with minimal oversight as required by operational area
Effectively assist in the execution of routine sample analysis studies with oversight
Perform data analysis in appropriate software for at least one analytical platform with oversight
Accurately write both study and non-study deviations with oversight
BA/BS or higher
Able to perform basic lab work
Able to work in a regulated environment
Able to work effectively and contribute within a team
Able to work with computer systems; able to document clearly
Performs and leads complex lab work, sample analysis, validation, and method development with limited supervision.
Numbers & Facts
Location
Malvern, PA
Skills
Analysis Skillsunmatched
Code of Federal Regulationsunmatched
Communication Skillsunmatched
Computer Systemsunmatched
Data Analysisunmatched
Environmental Protection Agency (EPA)unmatched
GCP (Good Clinical Practices)unmatched
GLP (Good Laboratory Practices)unmatched
GMP (Good Manufacturing Practices)unmatched
Identify Issuesunmatched
Laboratoryunmatched
Learning Content Management Systems (LCMS)unmatched
Regulatory Requirementsunmatched
Specimens/Samplesunmatched
Time Managementunmatched
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