Jose Hernandez

Jose Hernandez Email and Phone Number

Document Management | PLM Change Management | QMS | FDA-GMP Compliance/Validation, RCA/CAPA Implementation | Process Improvement | Proficient Technical Writer and Trainer @ AMRIS Consulting
kenly, north carolina, united states
Jose Hernandez's Location
Holly Springs, North Carolina, United States, United States
About Jose Hernandez

Highly skilled and result-driven professional with extensive technical writing, training, compliance, and validation experience within pharmaceutical FDA-regulated and automotive IATF/VDA-regulated industries. Well-versed in manufacturing compliance, document control, RCA, CAPA implementation, and process improvement. Adept at converting complex technical information into concise, cohesive, and compliant documents. Demonstrated ability to develop collaborative relationships and partnerships within a diverse organization. Strong analytical skills with a self-directed approach to gathering content and interviewing subject matter experts (SMEs). Committed to accomplishing goals and meeting deadlines, excellent attention to detail, and strong prioritization skills.

Jose Hernandez's Current Company Details
AMRIS Consulting

Amris Consulting

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Document Management | PLM Change Management | QMS | FDA-GMP Compliance/Validation, RCA/CAPA Implementation | Process Improvement | Proficient Technical Writer and Trainer
kenly, north carolina, united states
Website:
amrisconsulting.com
Employees:
10
Jose Hernandez Work Experience Details
  • Amris Consulting
    Consultant
    Amris Consulting Sep 2024 - Present
    Clayton, North Carolina, United States
    Novo Nordisk FFEx Site, Clayton / QA- QMS Specialist - Documentation
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  • Luminar Technologies
    Qa Document Control
    Luminar Technologies Jun 2018 - May 2024
    Orlando, Florida Area
    Oversaw all activities primarily associated with controlling Quality Management System (QMS) documents and records, including document change management implementation on the company's Product Lifecycle Management (PLM) platform. Managed the PLM Electronic Document Management System (EDMS) Lifecycle creation, distribution, revision, and obsoletion of our QMS documents. Provided system support, technical training, and maintained effective change control process tracking, including document change requests, collaborative reviews, and document change order approvals.
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  • Biogen
    Sr. Associate, Manufacturing Compliance
    Biogen Mar 2015 - Dec 2017
    Rtp, Nc
    Supported product transfer start-up for Tecfidera oral solid dosage (OSD) manufacturing and oligonucleotide synthesis manufacturing (OSM) following cGMP standards. Performed investigations and authored root cause analysis (RCA) for deviations across drug product sites. Developed and authored manufacturing SOPs and work instructions for parenteral, oral solid dose, and oligo synthesis facilities. Facilitated end-user technical training.
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  • Gannett Fleming
    Validation Specialist
    Gannett Fleming Jul 2013 - Mar 2015
    Raleigh-Durham, North Carolina Area
    Executed commissioning, qualification, validation, and verification documents; plans, protocols, test case scripts, risk assessments, traceability matrices, summary reports, and other documents supporting commissioning, qualification, validation, and verification of new and existing manufacturing equipment, processes, and products.
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  • Yoh Scientific Inc
    Validation Engineer
    Yoh Scientific Inc Apr 2012 - Jul 2013
    Raleigh-Durham, North Carolina Area
    Merck, Durham, NC - Executed equipment validation protocols and associated governing SOPs for controlled temperature units (CTUs). Initial set-up and distribution of validation test equipment and maintenance of tracking information. Managed the work schedule, system assessments, exceptions, and final reports as required. Reviewed study files and summary reports for accuracy and completeness. Participated in risk assessments, project follow-up, and other site initiatives as required.
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  • Amris Consulting
    Validation Consultant
    Amris Consulting Aug 2011 - Oct 2012
    Kenly, Nc
    Sandoz, Wilson, NC - Provided technical support to the DEA Compliance Department (Generic Pharmaceuticals facility) for revising and developing SOPs, forms, and training modules for their controlled substance procedures.Novo Nordisk, Clayton, NC - Developed qualification documentation for upgrading a cartoning system's glue station. Implemented operation verification protocol for the installation of a temporary cooling tower and revised the maintenance plan for a Sand Filtration Skid for a high-efficiency cooling water filtration system.
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Jose Hernandez Education Details

Frequently Asked Questions about Jose Hernandez

What company does Jose Hernandez work for?

Jose Hernandez works for Amris Consulting

What is Jose Hernandez's role at the current company?

Jose Hernandez's current role is Document Management | PLM Change Management | QMS | FDA-GMP Compliance/Validation, RCA/CAPA Implementation | Process Improvement | Proficient Technical Writer and Trainer.

What schools did Jose Hernandez attend?

Jose Hernandez attended Universidad Del Sagrado Corazón.

Who are Jose Hernandez's colleagues?

Jose Hernandez's colleagues are Jody Burgart, Pmp, Kandace Brown, Chad Osgood, Rob Levine, Joe Elphick, Rajesh Kumar, Brett Marcellus.

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