Pauline Acevedo Hernandez

Performed analytical tests on water samples following the different pharmacopeias (USP, EP, Ch P).

• Evaluated samples against standards by completing measurements, visual inspections and other established tests to stability and finish products(Tablets) and raw materials (API and Excipient) (Assay, CU,Dissolution, Identity, TLC, Water, Impurity, IR, KF, TOC, HPLC, Particle Size, PH, Bulk Density, Conductivity, Wet Chemistry).
• Work hand in hand with the R & D and Technical Services groups during the process of Validation of manufacturing processes and the transfer of methods to the analytical laboratory of new products introduced to the site.
• Worked hand in hand with the technical services team executing cleaning validation protocols, including sampling, testing and reporting results.
• Created, revised, updated, and/or obsolete SOPs/SOP Supplements.
• Performed the laboratory EHS audit as a member of the laboratory safety team.
• Followed safety and clean area procedures to comply with agency and regulatory mandates.

• Evaluated samples against standards by completing measurements, visual inspections and other established tests for stability and finish products (Tablets and capsules) ( Identity, IR and GC).
• Supported the implementation of the new chromatographic acquisition data system (EMPOWER 2) in the
  laboratory.
• Created static data and supported as part of the implementation team of the new Laboratory Information Management System (LIMS) Sample Manager 2004R2.

• Evaluated samples against standards by completing measurements, visual inspections and other established tests to stability and finish parenteral products. (Assay/Impurity and PH)
• Executed Validation protocols at the different stages of the manufacturing process.
• Coordinated activities to implement the 5’s initiative philosophy in the laboratory.
• Initiated the Change Control process for the equipment installation and qualification in the new facilities
  of the QC laboratory.

• Evaluated samples against standards by completing measurements, visual inspections and other established tests to stability and finish products (Tablets) (Description,
  Friability, Disintegration, Dissolution, Degradation and Impurity test, TLC, Assay, ID by Melting Point).