Shawn Hernandez

Supervisor, Operations & Compliance at U.S. Pharmacopeia

Role: Supervisor, Operations & Compliance at US Pharmacopeia
Location: Rockville, MD, US
LinkedIn followers: 500 followers

Manufacturing & ProductionView LinkedIn profile

About Shawn Hernandez

Extensive experience in progressive roles of responsibility within the pharmaceutical…

Experience

Supervisor, Operations & Compliance
US Pharmacopeia
Jul 2016 — Present · Rockville, MD, US
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• Providing technical leadership and global advocacy

Education

University of Florida
B.S. in Chemical Engineering
University of Florida
B.S. in Business Administration

Skills

Change Control
Six Sigma
Gxp
Glp
High-Performance Liquid Chromatography (Hplc)
Quality Control
Gmp
Equipment Repair
Spanish
Standard Operating Procedure (Sop)
Sop
Fda
Laboratory
V&V
Cleaning Validation
21 Cfr Part 11
Validation
U.s. Food and Drug Administration (Fda)
Hplc
American English
Microbiology
Calibration
Dissolution
Software Documentation
Capa
Technology Transfer

Contact information

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Work email
•••••@usp.org
Personal email
•••••@•••••.com
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Current company

US Pharmacopeia

Pharmaceutical Manufacturing · 1.7K employees · Founded 1820 · Rockville, Maryland, United States

US Pharmacopeia (USP) is an independent, scientific nonprofit organization that has focused on building trust in the supply of safe, quality medicines since 1820. We are a public health organization that uses rigorous science and public quality standards setting to protect patient safety and improve global health. We are committed to building public trust and confidence in drug therapies to enable people to live longer and healthier, and also work to building trust in dietary supplements and food ingredients. Currently, we are working to strengthen the global supply chain so that the medicines people rely on are available when needed and work as expected. Our Volunteers USP standards are in a continuous process of review and revision based upon new evidence, emerging public health concerns, and public requests for revision. Input from our volunteers, through our Council of Experts and Expert Committees and Panels, is crucial for maintaining our standards and preserving public trust. Our Governing Bodies The USP Convention helps guide our areas of impact – nearly 500 Member Organizations from around the world contribute valuable perspectives, experiences, and expertise from across healthcare and science. In addition to collaborating on critical healthcare and science matters, every five years, Convention Members adopt USP Resolutions and elect USP’s Board of Trustees and the Council of Experts who lead USP’s standards-setting Expert Committees. Visit www.usp.org to learn more.

usp.org

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