QC Compliance Specialist, 3rd Shift

Job description

The Quality Control Compliance Specialist plays a vital role on the QC team with analytical and microbiological testing experience. This role will support laboratory processing of finished product, incoming materials, and stability sample release. Essential Job Functions: This position will support primarily third shift (11 pm to 7:30 am) with occasional overtime support, dependent on operations’ needs. Perform in-depth technical data review of all analytical and microbiological testing performed on finished products - in-process samples, stability samples, raw material samples, and environmental samples, ensuring compliance with GMPs. Review includes both technical review of method performance as well as confirming data integrity elements, e.g. good documentation practices, audit trail reviews, etc. Generate QC data summary documents such as certificates of analysis and stability study summary reports. Provide SME support for electronic QC database systems and laboratory data integrity compliance (OpenLab etc) to support the QC laboratories. Revise and improve technical writing documents such as analytical methods, specifications, protocols, SOPs, templates, etc. Assist laboratory...