Data Control Clerk jobs in Madison, WI

The Position

The Quality Control Data Reviewer position will monitor the quality of laboratory data, reports and reviews analytical testing data along with related notebooks (or data packets) as specified by Standard Operating Procedures (SOPs). This position will evaluate data to ensure compliance with analytical methods, specifications, protocols and Good Manufacturing Practices (GMPs).

Responsibilities

• Evaluates laboratory data for compliance with analytical methods, specifications, protocols and SOPs
• Reviews sample results for completeness and accurate representation of the data and issues findings/corrections as needed
• Communicates with laboratory staff to proactively address the quality of laboratory documentation
• Prepares data review statements noting/reporting deficiencies with analytical data sets, notebook documentation, stability reports and certificates of analysis to responsible analysts for correction
• Conducts SOP review and authorship
• Performs other duties as assigned

Requirements:

• B.S. in Chemistry (or related field) required with 5 years of industry experience
• Thorough knowledge of SOPs and Federal Regulations (including GMP compliance)
• Thorough knowledge of standard pharmaceutical testing, with an emphasis on chromatographic data interpretation
• Strong technical knowledge including an understanding of laboratory procedures, methodology and standard practices
• 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
• Ability to work in a collaborative team environment