Scientist - The Fountain Group : Job Details

Scientist

The Fountain Group

Job Location : Social Circle,GA, USA

Posted on : 2024-12-17T07:36:31Z

Job Description :
The Fountain Group is currently seeking a Scientist for a prominent client of ours. This position is located in Social Circle, GA. Details for the position are as follows:Job Description:**100% ONSITE**
  • Expertise and technical leadership managing instrument/method validations change requests and improvement initiatives.
  • Lead/Manage assay qualification and validation activities for QC, including authoring and/or reviewing protocols, coordinating testing with the functional area managers, performing statistical data analysis and final summary reports per ICH and internal guidelines.
  • Lead investigator providing technical and analytical representation for, with strong understanding of compliance and cGMP's, strong scientific judgment and leadership in decision making.
  • Coordinate analytical support within QC necessary to identify root cause.
  • Facilitate major investigations, review of change control requests, provide representation to tech transfer as needed, review of process and method validation initiatives in support of the QC laboratories.
  • Provide technical expertise and support for monitoring/assessing analytical method performance, troubleshooting and assay remediation.
  • Manage and contribute to cross functional teams.
  • Lead management of the document change requests for method SOPs.
  • Works on problems of diverse scope in which analysis of situation or data requires evaluation of identifiable factors.
  • Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
  • Acts as advisor to subordinates to meet schedules and/or resolve technical problems.
  • Supporting regulatory activities including, but not limited to regulatory inspections and filings related to general analytical methodologies.
Qualifications:
  • BS, MS, or PhD
  • Extensive GMP/CMC pharma experience (7+ years)
  • Chromatography/Spectroscopy experience
  • Analytical Method Validation
Compensation: Up to $83.93 per hour
Apply Now!

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