QC Data Reviewer
Raleigh Metro Area, NC
Perform data review for QC Chemistry testing to support release of raw materials, drug substance, and drug product in a GMP environment. Strong scientific and data review background as to provide technical knowledge and quality comments associated with raw data review and documentation. Strong background in compendial and/or raw material testing.
Perform timely data review (chromatography and other data) with a high focus on data quality to ensure accuracy, completeness, cGMP compliance, and neatness of analytical documentation
Reviews testing for accuracy, completeness, cGMP compliance, and neatness of analytical documentation
Must be able to understand and interpret data ((chromatography and other data)
Verify calculations and documented information such as reagent expiry, reagent preparation, instrument calibration, logbook entries, control charts, etc. are present, complete and accurate.
Verify that all analysis performed were as per methodology and/or compendial methods, and were in compliance with GMP requirements.
Assist laboratory with regard to Out-of-Specification investigations.
Perform weekly logbook checks
Monitor LIMs data for items that require data review and manager review.
Review data for trends
Ability to work effectively under pressure to meet deadlines
5 years + of pharmaceutical/GMP testing experience coupled with a minimum of 2 years performing data review.
Compendial Testing and/or review of compendial testing
GMP experience is a must
Advanced knowledge of analytical methods and testing and related instrumentation.
Strong attention to detail
Advanced knowledge of GMPs, safety regulations, LIMS, data integrity
Minimum: BS degree in Chemistry, or other related scientific field