Ashley Werner

Ashley Werner Email and Phone Number

Director QS and RA @ Nexpring Health
Rancho Santa Margarita, CA, US
Ashley Werner's Location
Rancho Santa Margarita, California, United States, United States
Ashley Werner's Contact Details

Ashley Werner personal email

n/a
About Ashley Werner

Ashley Werner is a Director QS and RA at Nexpring Health. She possess expertise in environmental monitoring in iso 6 and 7 clean rooms, endotoxin testing by lal gel clot and kinetic chromogenic, moisture analysis by karl fischer titration, managerial skills, fda and 6 more skills. She is proficient in Spanish.

Ashley Werner's Current Company Details
Nexpring Health

Nexpring Health

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Director QS and RA
Rancho Santa Margarita, CA, US
Employees:
312
Ashley Werner Work Experience Details
  • Nexpring Health
    Director Qs And Ra
    Nexpring Health
    Rancho Santa Margarita, Ca, Us
  • Fujifilm Irvine Scientific
    Director Global Regulatory Affairs & Product Compliance
    Fujifilm Irvine Scientific Apr 2022 - Present
    United States
  • Irvine Scientific
    Associate Director Global Ra/ Product Compliance
    Irvine Scientific Jun 2021 - Aug 2022
    Santa Ana, California
    Oversee global regulatory affairs and product compliance for FUJIFILM Irvine Scientific Inc.
  • Fujifilm Irvine Scientific
    Sr. Manager Global Regulatory Affairs & Product Compliance
    Fujifilm Irvine Scientific Oct 2017 - Jun 2021
    Santa Ana, California, United States
    Manage global regulatory
  • Zimmer Biomet
    Senior Quality Assurance Specialist
    Zimmer Biomet Jul 2014 - Oct 2017
    Scottsdale, Az
  • Irvine Scientific
    Qc Manager
    Irvine Scientific Jul 2011 - Jul 2014
    • Ensured laboratory compliance to cGMP and GLP• Directly supervised Level I, II and III Mircobiologists • Re-structured Stability Program to ensure compliance to ICH, 21CFR211.166 and FDA• Ensured all testing methods were validated and followed compendia standards
  • Irvine Scientific
    Project Manager
    Irvine Scientific Jan 2010 - Jul 2011
    ● Maintained robust custom's program to ensure on-time delivery of highest quality products to customers ● Managed all internal custom projects and reported directly to Quality Director and COO ● Served as team leader for several critical projects: including milling technology conversion, ramp-up production requests and Custom Media Optimization Projects ● Worked as internal point of contact for 6 Sales and Territory Managers in all global locations ● Worked directly with customers, providing support and assistance
  • Irvine Scientific
    Qc Lead Microbiologist
    Irvine Scientific Jul 2008 - Jan 2010
    ● Assisted in supporting the regulatory filling and 510K and CE marking of over 60 ART products ● Improved ICC cell culture program including revamping the company's cell banking program to include a master and working cell bank for all cell lines ● Directly reported to Quality Director and worked as "acting manager" for 8 months while QC manager position was vacant

Ashley Werner Skills

Environmental Monitoring In Iso 6 And 7 Clean Rooms Endotoxin Testing By Lal Gel Clot And Kinetic Chromogenic Moisture Analysis By Karl Fischer Titration Managerial Skills Fda Glp Gmp Medical Devices Quality Control Validation Quality System

Ashley Werner Education Details

Frequently Asked Questions about Ashley Werner

What company does Ashley Werner work for?

Ashley Werner works for Nexpring Health

What is Ashley Werner's role at the current company?

Ashley Werner's current role is Director QS and RA.

What is Ashley Werner's email address?

Ashley Werner's email address is aw****@****cal.com

What is Ashley Werner's direct phone number?

Ashley Werner's direct phone number is +194924*****

What schools did Ashley Werner attend?

Ashley Werner attended Northern Arizona University.

What skills is Ashley Werner known for?

Ashley Werner has skills like Environmental Monitoring In Iso 6 And 7 Clean Rooms, Endotoxin Testing By Lal Gel Clot And Kinetic Chromogenic, Moisture Analysis By Karl Fischer Titration, Managerial Skills, Fda, Glp, Gmp, Medical Devices, Quality Control, Validation, Quality System.

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