Quality Scientist (m/f/d)

Your Profile:

Minimum Qualifications:
• Bachelor's Degree in Chemistry, Biology, or other life science field.
  
  Preferred Qualifications:
• 3+ years of GMP experience in pharmaceutical, biopharmaceutical or chemistry.
  
• Excellent attention to detail.
  
• Intermediate knowledge of Word and Excel.
  
• Technical knowledge of wet chemistry, chromatography, and electrophoretic testing.
  
• 1+ years of experience with analytical method validation.
  
• Effective communication in cross-functional teams.

Your Tasks:

In this role you will be responsible for reviewing the documentation and data generated for analysis of GMP products. This review may include data supporting raw materials, in-process and/or final products. You will be responsible for verifying that documentation and raw data meet good documentation requirements, are technically acceptable, all calculations are appropriate and correct, and specifications are met. Additional expectations may include the review of new or updated procedures for both technical soundness and allowance for appropriation documentation. Review of audit trails, data integrity, and GDP required. Importantly, you will have primary responsibility for review of raw data, protocols and reports for all analytical method undergoing validation. You will be critical in ensuring that validated methods support the final product specifications through review of procedural updates after validation activities are complete.

This is a Monday - Friday Day shift position

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