Understand OOS/Investigative reports and notify management immediately of nonconforming data or unexpected occurrences, and help determine appropriate corrective and preventive actions (CAPA) to address mitigation of investigation assignable cause.
November 07, 2022
Provide cGMP compliant laboratory technical support to Manufacturing/Operations in the form of method validation, testing, documentation .
November 20, 2022
Review laboratory/chemistry reports to ensure no errors in calculations or findings, reviewing for technical accuracy and compliance.
December 10, 2022
Demonstrated ability to apply good laboratory techniques while maintaining the efficiencies required in Quality Control.
February 26, 2023
Support the non-conforming materials system including ensuring compliance to procedures, performing root cause analyses, performing trend analyses, developing and implementing corrective actions.
March 07, 2023
Assist support of overall operations, customer service, product quality, regulatory compliance, on-time shipping, customer satisfaction and business objectives.
March 22, 2023
Prepares and standardizes test/volumetric solutions, standard solutions and samples for various chemical and physical test according to approved methods, perform and lead others in performing complex analyses including, but not limited to HPLC, GC, IC, UV-Visible Spectrophotometry, FTIR, and Karl Fischer.
April 02, 2023
Performs testing of raw materials, in-process, finished product and/or stability samples including dissolution, assay, content/blend uniformity, particle size distribution, and other tests according to the analytical methods, USP, procedures in a regulated laboratory environment.
April 03, 2023
Follows all SOPs, Safety Guidelines and good housekeeping practices to ensure compliance with cGMP and Tris Safety and Housekeeping requirements.
April 25, 2023
Participate/support/lead Site Quality Initiatives to reduce non-value added work and improve overall quality performance.
May 15, 2023