QC Method Validation Engineer
Description
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)
● Develop Transfer/Validation/Verification protocols for QC Analytical Methods
● Develop method SOPs for multiple materials
● Demonstrated method troubleshooting capability
● Knowledge, skills, and expertise in performing chemical experiments that involve the use of liquids, or "wet" chemicals
● Preparing chemical solutions, conducting chemical reactions, and analyzing chemical compounds using various wet chemical techniques such as titrations, extractions, filtrations, and precipitation.
Qualifications:
● Bachelor's Degree or superior
● 5 years of manufacturing, quality or engineering in the biotech or pharmaceutical industry with a BS/BA Degree in Science/related field
● Strong understanding of the underlying principles of chemistry, as well as knowledge of laboratory safety and best practices
● Strong experience with ICH Q2 method qualification/validation requirements
● Strong experience with the USP, EP, and JP Pharmacopeia
● Hands-on analytical instrumentation experience is preferred.
● Hands-on analytical raw materials experience is preferred.
● Knowledge of Good Manufacturing Practices {also cGMP} compliance requirements for Quality Control Laboratories, and experience with a wide range of analytical techniques.
● Strong verbal and written communication skills
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