Qureos Mentor

GForce Life Sciences

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 Summary
 
 
 
 Our growing, mid-sized pharmaceutical client has engaged GForce Life Sciences to provide a Scientist Consultant (QC/AS) to support the client's studies of developmental, clinical, and commercial pharmaceutical and related products
 
 
 
 
 
 
 Duties / Expectations of Role
 
 
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 Reviews analytical data, including raw data, of developmental, clinical, and commercial pharmaceutical and related products for accuracy and compliance with the client's GxP requirements.
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 Initiate and monitor stability studies of developmental, clinical, and commercial pharmaceutical and related products tested by contract laboratories.
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 Reviews, enters, and maintains stability data for developmental, clinical, and commercial pharmaceuticals and related products.
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 Create studies in LIMS for multiple projects
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 Enter or review sample test result data in LIMS
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 Assists in technical investigations; enters deviations and investigations into Trackwise
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 Maintain and manage analytical testing documentation, including protocols, reports, and data, in compliance with good documentation practices (GDP) and data integrity standards.
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 Prepare stability reports and summaries for inclusion in INDs, NDAs, and regulatory submissions, ensuring accuracy, completeness, and adherence to regulatory requirements.
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 Use descriptive statistical techniques to organize and summarize data
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 Based on project needs, use statistical analysis techniques to identify patterns and trends
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 Create graphs, profiles, and reports of testing and/or stability data and statistical analysis
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 Assist the project team in making informed business decisions based on data insights
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 Required experience:
 
 
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 Bachelor&rsquo;s degree in chemistry or related science + 3-5 years work experience in a GXP environment focused on analytical laboratory testing of pharmaceuticals and related materials
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 Familiarity in GMP environment focused on analytical laboratory testing, including HPLC, Dissolution, etc.
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 Experience in data review
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 Nice to have
 
 
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 Experience with electronic document management systems &ndash; Veeva, CREDO, etc.
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 Experience with investigation software (Trackwise preferred)
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 Term &amp; Start
 
 
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 12-month contract - option to extend
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 Paid Federal Holidays for W2
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 Health Insurance available
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Analytical Scientist

Join GForce Life Sciences and explore 2   exciting career opportunities. They're hiring for various roles with options for remote or on-site work. Apply today and become part of their innovative team.

GForce Life Sciences

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Analytical Scientist

Analytical Scientist