Shawn Hernandez Email & Phone Number

Rockville, MD, US

Rockville, MD

• Responsible for leading process collaboration and harmonization across global sites
• Responsible for driving ISO compliance for global analytical laboratories
• Responsible for timely operational support for US based analytical laboratories
• Strengthening QA and QC systems
• Increasing the supply of quality assured medicines
• Combating the availability of substandard and counterfeit medicines

Cary, NC

• Assist family and friends in capital management.
• Provide noise inspection services for clients interested in assessing residential noise.
• Saved capital and trained to independently travel and trek throughout Argentina, Chile and Peru.
• Bought a house on a short sale and have fixed most major issues.

RTP, NC

• Provided technical and regulatory expertise in creating, reviewing and approving calibration methods, validation protocols, standardized operating procedures, deviations, user requirements, functional specifications.
• Responsible for auditing and performing gap analysis on MDI, DPI, and injectable manufacturing equipment lines and utilities for clinical batches.
• Reviewed, created, and approved CSV validation documentation for major analytical equipment including HPLC, DSC, TGA, AA.
• Primary spokesman during corporate and customer audits for validation inquiries.
• Created new manufacturing equipment and analytical instrumentation onboarding processes and procedures based on current USP <1058> and GAMP 5 guidance to streamline and define a process for quicker validation turnaround.
• Addressed a critical business need from utilization data from over 140 HPLCs by creating a software solution to read, aggregate, and store the data. The information generated was used to redeploy assets across the site.

India

• Authored a grant proposal on solid waste management.
• Assisted landslide victims with relocation efforts and supplies.
• Saved capital to independently travel and volunteer throughout India, Nepal, Thailand, and Malaysia.
• Provided care for injured and abandoned animals.

Chantilly, VA

• Created an internal website that served as a repository for information from drug discovery tocommercialization that allowed end users to edit their own information easily with zero capital investment, essentially a.
• Created a project management tool with access restrictions that focused on API characterization allowing managers and directors the ability to write, store and share information.
• Administrator on both Waters/Empower and Agilent/Chemstation and responsible for troubleshooting, data archival, and project creation.
• Discovered an error inherent in Chemstation that caused the UV system to incorrectly subtract out blank measurements in a multicell deployment. Found a workaround as software updates had not and would notaddress the.
• Responded to questions posed by FDA officers during a project audit resulting in no observations.
• Validated computer systems including excel spreadsheets, macros and analytical software packages.

Miami, FL

• Responsible for responding to select FDA audit questions in written format.
• Initiated and executed validation and qualification protocols for analytical equipment.
• Drafted methods for testing raw material, in-process and finished products.
• Trained chemists on equipment and method usage.
• Responsible for maintenance of equipment calibrations; specified and ordered analytical equipment.
• Implemented bioavailability/bioequivalency studies for the testing of aqueous nasal sprays and inhalers.

Bolivia

• Designed, implemented, managed, and maintained water and sanitation projects for 35 communities.
• Assisted other volunteers with fluid flow designs and proposals for new potable water projects.
• Worked with the Bolivian government to start a partnership for the use of technical analytical equipment.
• Presented water disinfection methods to local communities.

Gainesville, FL

• Designed and executed moisture experiments for industry to investigate the absorption properties of fibers at differing humidity.
• Assisted with research on a novel invention the BLMT (Boundary Layer Momentum Transfer) Classifier.
• Credited on the following paper: “Centrifugal Air Classification of Fine Particles Using Rotating Disks”.
• Brought an environmental chamber online and wrote an instructional booklet for the outdated microcontroller.

B.S. In Chemical Engineering

Activities and Societies: Honors Program National Hispanic Scholar Florida Merit Scholar

B.S. In Business Administration, With A Concentration In Decision Information Sciences (Databases And Networking)