QC Method Validation Engineer

Essential Duties and Responsibilities:

●        Validation of quality control instruments (spectrometers) including the following:

• Review of turnover packages (TOPs) and applicable work instructions
• Review and update User Requirements Specifications (URS) and generate system design and configuration specifications
• Review and update instrument operations and maintenance Standard Operating Procedures (SOPs)
• Manage/support vendor instrument IOQ process and develop/execute appropriate PQ protocols
• Author PQ final reports including trace matrices and data integrity assessments

●        Develop and execute test method transfers/validation/verification protocols for the following analytical techniques:

• Raman spectrometer (real-time raw material analysis)
• FT-NIR spectroscopy (rapid content uniformity testing)
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