Chromatography Data Reviewer

The Position

The Chromatography Data Reviewer will monitor the quality of laboratory data and reports and review analytical testing data and related notebooks as specified by Standard Operating Procedures (SOPs). This position will evaluate data to ensure compliance with analytical methods, specifications, and Good Laboratory Practices (GLP) or Good Manufacturing Practices (GMP).

Responsibilities:

• Evaluates laboratory data for compliance with analytical methods, specifications, and SOPs
• Reviews sample results for completeness and accurate representation of the data and report findings
• Communicates with laboratory staff to proactively address the quality of laboratory documentation
• Prepares statements noting deficiencies with the analytical data set or notebooks and reports deficiencies to the project leader for correction
• Conducts SOP review and writing. Conducts consultations for quality records
• Performs other duties as assigned

Requirements:

• Bachelor's degree or equivalent experience required
• Thorough knowledge of SOPs and Federal Regulations including GLP and GMP
• Thorough knowledge of standard pharmaceutical testing, especially analysis by chromatography, and divisional SOPs
• Strong technical knowledge including an understanding of laboratory procedures, methodology, and standards
• Strong verbal and written communication skills
• Strong attention to detail
• Ability to independently review laboratory reports as well as analytical methods and test results
• Ability to deal with multiple and changing priorities
• Ability to provide clear and concise feedback and/or documentation of results
• Ability to work in a collaborative team environment