Review Batch Records, RMSs, QC test reports, Oven Autoclave Cycles, Calibration Records, and
Environmental Monitoring Records for lot disposition according to specifications.
Review and edit SOPs, BPRs and Manufacturing Formulation Records as required.
Participate in gathering information for investigations.
File, track, and archive documents.
Maintaining files and file copying.
Collect data and maintain databases for the manufactured product and documentation compliance.
Organize and Compile BHR binders and maintain updated inventory of all products manufactured
Review, update and organize documents prior to lot disposition.
Track employee training and maintain records.
Compile trend NCMRs & DRs, on materials, processes and products to ensure that company quality
standards are met.
Assist in the training of Employees on Quality Systems.
Assist in the development, implementation and maintenance of quality assurance systems and
activities in support of manufacturing.
Ensure that assessment, control, inspection and sampling of raw materials, packaging
materials, in-process products and finished goods is performed consistent with cGMP, and
Assure revision levels on documents are correct when used for manufacture of product and QC
testing at the beginning (raw material), intermediate (in process), and final stages of
production (Final Product).
Verify labels generated by Quality Control Unit for raw materials and final product vials.
Additional duties as assigned.