Efficiently perform and document all procedures, materials and results in compliance with applicable regulatory standards as applicable (protocols, methods, SOPs, etc.)
Effectively demonstrates behaviors and performance characteristics as described in our core values
Develop and maintain understanding of regulatory requirements (GLP, GCP, GMP, EPA, OECD, CLIA, 21CFR Part 11) and apply as required by operational area
Demonstrates effective communication skills through both informal and formal discussions with peers, supervisor, internal teams, and externally with Regulators
Develop and maintain 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
Independently and accurately prepare reagents. Accurately prepare standards and control samples with oversight
Independently and accurately perform laboratory support functions such as labeling, monitoring expiration dates, and solution preparation
Independently operate and maintain analytical instruments as required by operational area
Independently and effectively execute routine sample analysis studies
Independently and accurately perform data analysis in appropriate software for a least one analytical platform, while performing analysis for additional platforms within an operational area with oversight.
Accurately write both study and non-study deviations with minimal oversight
Demonstrates a developing understanding what constitutes a passing or failed run
Effectively review laboratory documents and notebooks (e.g., plans, experiment/sample runs, validation files, reports, chromatograms, instrument logs, etc.) for compliance to SOPs and applicable regulations with minimal oversight as required by operational area. Accurately review system audit trails with oversight as required by operational area as needed
Accurately executes method validation and qualification projects as required by operational area with oversight
Actively participate in process improvement initiatives with oversight
Maintains an awareness of team workload and provides support to other staff members as needed
Effectively assist in method development and transfer projects as required by operational area, with oversight of scientific staff
BA/BS or higher in Chemistry or Biochemistry with 1+ years lab experience; all experiences will be evaluated
Knowledge and understanding of regulatory requirements; GLP, GCP, 21CFR Part 11, GDP, GMP
Able to independently perform complex 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
Numbers & Facts
Location
Malvern, PA
Skills
Analysis Skillsunmatched
Biochemistryunmatched
Chemistryunmatched
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
Information Technology/Systems Auditunmatched
Laboratoryunmatched
Laboratory Notebookunmatched
Learning Content Management Systems (LCMS)unmatched
Process Improvementunmatched
Regulationsunmatched
Regulatory Complianceunmatched
Regulatory Requirementsunmatched
Standard Operating Procedures (SOP)unmatched
Time Managementunmatched
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