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Scientist I Immunoassay

Alliance Pharma Inc

  • Malvern, PA
  • 30+ days ago

    Highlights

    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. 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.

    Numbers & Facts

    LocationMalvern, PA

    Description

    • 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 Biology 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

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