Essential Duties and Responsibilities:
● Validation of quality control instruments (spectrometers) including the following:
Review of turnover packages (TOPs) and applicable work instructionsReview and update User Requirements Specifications (URS) and generate system design and configuration specificationsReview and update instrument operations and maintenance Standard Operating Procedures (SOPs)Manage/support vendor instrument IOQ process and develop/execute appropriate PQ protocolsAuthor 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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