Summary
Overview
Work History
Education
Skills
Certification
Timeline
Generic

Kari Williams

Chicago,IL

Summary

Nearly 13 years of professional experience in diverse roles in pharmaceuticals specifically with CSL Behring. Detail-oriented individual with exceptional communication and project management skills. Proven ability to handle multiple tasks effectively and efficiently in fast-paced environments. Recognized for being a proactive and goal-oriented professional with excellent time management and problem-solving skills. Known for reliability and adaptability, with a swift capacity to learn and apply new skills.

Overview

21
21
years of professional experience
1
1
Certification

Work History

Global Regulatory Affairs Scientist

CSL Behring
05.2022 - Current
  • Lifecycle manages the content of the dossiers.
  • Collaborates with cross functional teams and sister sites to develop regulatory strategies.
  • Prepares and files regulatory submissions to the appropriate health authority.
  • Ensures the submission package is in compliance with health authority guidance documents and technical requirements.
  • Reviews technical documentation such as validation or stability reports to ensure compliance with regulatory standards.
  • Assists with regulatory site inspections to ensure adherence to industry standards and internal policies, maintaining a high level of compliance throughout the organization.
  • Performs regulatory assessments for deviation investigations and global change controls.
  • Utilizes TrackWise, docNet, GDRS, Plateau, Veeva, Apollo and docuBridge regularly.

Parenteral Manufacturing Subject Matter Expert

CSL Behring
03.2017 - 05.2022
  • Developed and implemented process improvement initiatives that increased productivity and streamlined workflows.
  • Led cross-functional teams to enhance process efficiency.
  • Established best practices for process documentation, ensuring clarity and consistency across operations.
  • Developed strong cross-functional relationships to ensure seamless communication among departments.
  • Collaborated with stakeholders to define project scope, objectives, and deliverables, ensuring alignment with business goals.
  • Handled escalations from stakeholders; swiftly resolved issues while maintaining positive working relationships.
  • Facilitated regular meetings with team members to track progress, discuss challenges, and share best practices.
  • Assisted with regular departmental audits and regulatory site inspections to ensure adherence to industry standards and internal policies, maintaining a high level of compliance throughout the organization.
  • Trained and guided staff on aseptic techniques to maintain the highest standards.
  • Managed change among staff to explain the 'why' and achieve cooperation to overcome resistance.
  • Utilized TrackWise, docNet, SAP, Lab Ware, StarLIMS, GDRS and Plateau regularly.

Senior Quality Assurance Specialist

CSL Behring
10.2012 - 03.2017
  • Conducted root cause analysis on quality failures, driving corrective action plans to mitigate future risks.
  • Collaborated with cross-functional teams to identify areas for process improvement.
  • Led quality assurance initiatives to enhance product compliance with industry regulations and standards.
  • Conducted regular departmental audits to ensure adherence to industry standards and internal policies, maintaining a high level of compliance throughout the organization.
  • Led training on best practices in quality assurance for both new hires and existing team members, promoting knowledge sharing.
  • Utilized TrackWise, docNet, SAP, Lab Ware, Plateau, Fishbone diagrams and 5-Why’s.

Quality Assurance Specialist - Contractor for CSL Behring

Aerotek Recruiting
04.2012 - 10.2012
  • Conducted root cause analysis on quality failures, driving corrective action plans to mitigate future risks.
  • Collaborated with cross-functional teams to identify areas for process improvement.
  • Led quality assurance initiatives to enhance product compliance with industry regulations and standards.
  • Conducted regular departmental audits to ensure adherence to industry standards and internal policies, maintaining a high level of compliance throughout the organization.
  • Utilized TrackWise, DCMS, SAP, Lab Ware, and Plateau.

Cashier

Menards
04.2004 - 10.2012
  • Worked with floor team and managers to meet wide range of customer needs.
  • Maintained a balanced cash drawer, ensuring accurate accounting at the end of each shift.
  • Processed customer transactions accurately and efficiently at checkout stations.
  • Resolved customer issues promptly, ensuring satisfaction and loyalty.
  • Assisted customers with returns, refunds and resolving transaction issues.
  • Trained new cashiers on register operations and customer service protocols.
  • Built relationships with customers to encourage repeat business.

Education

Bachelor's Degree - Science

Saint Xavier University
05-2009

Skills

  • Strong Work Ethic
  • Works Well Under Pressure
  • Highly Responsible and Reliable
  • Problem Solver/Critical Thinker
  • Exceptional Attention to Detail
  • Organizational Skills
  • Effective Communication
  • Task Prioritization
  • Interpersonal Skills
  • Scientific Writing
  • Easily Approachable
  • Quick Learner
  • Project Management
  • Technical Oversight
  • Effective Multitasking
  • Self-Directed and Motivated
  • Team Collaboration
  • Time Management

Certification

Parenteral Drug Association (PDA) 100 Aseptic Processing Course – 2018

Timeline

Global Regulatory Affairs Scientist

CSL Behring
05.2022 - Current

Parenteral Manufacturing Subject Matter Expert

CSL Behring
03.2017 - 05.2022

Senior Quality Assurance Specialist

CSL Behring
10.2012 - 03.2017

Quality Assurance Specialist - Contractor for CSL Behring

Aerotek Recruiting
04.2012 - 10.2012

Cashier

Menards
04.2004 - 10.2012

Bachelor's Degree - Science

Saint Xavier University

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