Amanda Kapp

Amanda Kapp Email and Phone Number

Quality Specialist @ Thermo Fisher Scientific
Jefferson City, MO, US
Amanda Kapp's Location
Jefferson City, Missouri, United States, United States
Amanda Kapp's Contact Details

Amanda Kapp personal email

n/a

Amanda Kapp phone numbers

About Amanda Kapp

Amanda Kapp is a Quality Specialist at Thermo Fisher Scientific. She possess expertise in capa, gmp, fda, change control, quality system and 23 more skills.

Amanda Kapp's Current Company Details
Thermo Fisher Scientific

Thermo Fisher Scientific

View
Quality Specialist
Jefferson City, MO, US
Website:
thermofisher.com
Employees:
99360
Amanda Kapp Work Experience Details
  • Thermo Fisher Scientific
    Quality Specialist
    Thermo Fisher Scientific
    Jefferson City, Mo, Us
  • Solventum
    Quality Specialist
    Solventum Apr 2024 - Present
    United States
  • 3M
    Quality Specialist
    3M Aug 2016 - Apr 2024
    Columbia, Missouri
  • Abb
    Iso Quality Engineer
    Abb Jun 2014 - Jul 2016
    Jefferson City, Missouri
  • Bayer Healthcare
    Compliance Quality Auditor Ii
    Bayer Healthcare Jan 2013 - Jun 2014
    Saint Joseph, Missouri
    Site lead for the Quality Cross Contamination Risk Management Program and other quality risk management programs associated with Aseptic Parenteral (hormone, potent, non-potent), Non-Sterile Liquids, and Solid Oral Dose manufacturing. Execute detailed Failure Mode and Effectiveness Analysis as related to evaluate process risk. Oversee the impact of changes to manufacturing facilities, manufacturing process and work procedures as related to risk management program. Implement policies and SOPs related to Quality Risk Management and change control. Execution of the Corrective Action Preventative Action (CAPA) / quality investigation program. Execution of incident and deviation reports, impact assessments, trend analysis, chemistry and microbiological laboratory investigations, CAPA, effectiveness and CAPA review board. Upon incident recognition determine impact/risk to proceed.Responsible for the planning, execution, tracking, and completion of key supplier audits (API, excipient, components, etc.). This function assesses the supplier’s capability of meeting manufacturing standards. The various standards could include ISO, FDA, cGMP, EU, PIC/S, etc. Responsible for maintaining working knowledge of cGMPs and emerging regulatory and compliance concerns. Act as lead auditor to complete internal/on-site audits.Assists supervisors, managers and other more senior individuals with investigation root cause analysis and assignment of corrective and preventive actions for Quality Investigations.Demonstrates competent understanding and use of technical standards, principles, theories, concepts and techniques for audit work as well as reviewing and writing SOP training guidelines associated with the groups’ job function.Provide training to BAH personnel on investigational procedures and guidance for Quality issues, as applicable. Mentor and Develop Quality staff, which includes professional staff.Experience in FDA Consent Decree remediation.
  • Teva Pharmaceuticals
    Compliance Quality Auditor Ii
    Teva Pharmaceuticals Apr 2012 - Jan 2013
    Saint Joseph, Missouri
  • Hospira, Inc.
    Supplier Quality Engineer
    Hospira, Inc. Jun 2002 - Apr 2012
    Mcpherson, Ks
    Oversees compliance of API, Excipient, Component, Pkg Materials, and Device suppliers for Hospira, Inc.
  • Hospira, Inc
    Contract Mfg Analyst
    Hospira, Inc Jun 2010 - Jan 2012

Amanda Kapp Skills

Capa Gmp Fda Change Control Quality System Manufacturing Aseptic Processing Pharmaceutical Industry Quality Assurance Root Cause Analysis Sop Quality Control 21 Cfr Part 11 Quality Auditing Validation Lean Manufacturing Iso Supplier Quality Iso 13485 Contract Manufacturing 5s Medical Devices U.s. Food And Drug Administration Auditing Standard Operating Procedure Trackwise Iso Standards Corrective And Preventive Action

Amanda Kapp Education Details

Frequently Asked Questions about Amanda Kapp

What company does Amanda Kapp work for?

Amanda Kapp works for Thermo Fisher Scientific

What is Amanda Kapp's role at the current company?

Amanda Kapp's current role is Quality Specialist.

What is Amanda Kapp's email address?

Amanda Kapp's email address is ak****@****mmm.com

What is Amanda Kapp's direct phone number?

Amanda Kapp's direct phone number is +157346*****

What schools did Amanda Kapp attend?

Amanda Kapp attended Minot State University.

What skills is Amanda Kapp known for?

Amanda Kapp has skills like Capa, Gmp, Fda, Change Control, Quality System, Manufacturing, Aseptic Processing, Pharmaceutical Industry, Quality Assurance, Root Cause Analysis, Sop, Quality Control.

Who are Amanda Kapp's colleagues?

Amanda Kapp's colleagues are Julius Cano, Mba, Malia Ursida, Jeremy Welsh-Kavan, Avila Tirzo, Shiqi Su, Marwan Salam, Hans Den Boer.

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