Summary
Overview
Work History
Education
Skills
Certification
Hobbies: Fishing, Boxing, Taekwondo
Timeline
Generic

Laura Lis

Pennsburg,PA

Summary

Proven leader in technical operations at Charles River Laboratories, adept in change control and fostering teamwork. Streamlined validation processes, enhancing efficiency and compliance. Mentored staff, contributing to professional growth. Expertise in GLP knowledge and problem-solving, significantly improving project outcomes.

Experienced leader with strong background in guiding teams, managing complex projects, and achieving strategic objectives. Excels in developing efficient processes, ensuring high standards, and aligning efforts with organizational goals. Known for collaborative approach and commitment to excellence.

Equipped with strong problem-solving abilities, willingness to learn, and excellent communication skills. Poised to contribute to team success and achieve positive results. Ready to tackle new challenges and advance organizational objectives with dedication and enthusiasm.

Innovative technology professional with several years of diverse experience. Skilled in enhancing systems and aligning technical solutions with business objectives. Proven success in leading projects from start to finish and contributing to organizational growth and success.

Overview

21
21
years of professional experience
1
1
Certification

Work History

Validation Specialist

Charles River Laboratories
01.2008 - 09.2024
  • Conducted thorough root cause analyses to address deviations during validation activities, implementing corrective actions as needed.
  • Identified areas for improvement in existing validation systems, recommending changes that led to increased efficiency.
  • Led the training of junior team members on validation principles and techniques, fostering a culture of continuous learning within the organization.
  • Managed change control initiatives ensuring that all system modifications underwent proper revalidation before implementation into production environments.
  • Collaborated with cross-functional teams to ensure timely completion of validation projects, meeting regulatory requirements.
  • Supported internal audits by providing necessary documentation related to validation efforts, ensuring compliance with established standards.
  • Maintained excellent communication with stakeholders throughout validation projects, keeping them informed about progress and potential challenges.
  • Collaborated on Standard Operating Procedure (SOP) development, incorporating input from [Type] team to reduce liability and enhance successful deployments.
  • Explained highly complex information in terms easily understood by non-technical personnel.
  • Led risk assessment meetings, offering input on assessments such as system impact, component criticality, data integrity, and other factors.
  • Collaborated with cross-functional teams for identification and resolution of validation issues.
  • Developed validation master plans, process flow diagrams and standard operating procedures.
  • Produced and maintained technical documentation for project reference.

Manager of Technical Operations

Charles River Laboratories
01.2008 - 04.2018
  • Updated and published standard operating procedures (SOPs) using stakeholder, customer and employee input and feedback resulting in clearer and more useful instruction for users.
  • Contributed to business growth by participating in strategy development meetings with senior management.
  • Mentored junior staff members, fostering a culture of continuous learning and professional development.
  • Oversaw daily operational activities within the technical department, including resource allocation, workload distribution, and priority setting.
  • Championed process improvement initiatives that led to increased efficiency across technical operations teams.
  • Successfully managed multiple high-priority projects concurrently while maintaining strict deadlines and budgets.
  • Fostered a positive work environment by cultivating open lines of communication among team members.
  • Managed implementation of new technological improvements resulting in increased efficiency.
  • Provided ongoing training and development for research staff.

Study Supervisor

Charles River Laboratories
01.2004 - 01.2008
  • Identified areas of improvement in study processes, leading to increased productivity and cost-effective solutions.
  • Managed diverse study protocols, balancing competing priorities for successful execution of multiple projects simultaneously.
  • Mentored junior staff members, contributing to their professional growth and enhancing team performance overall.
  • Led regular departmental meetings with internal teams, ensuring transparency and alignment on processes and study progress.
  • Managed aspects of study close-out, ensuring thorough data review and timely delivery of study data submission.
  • Enhanced study efficiency by implementing effective project management strategies and tools.
  • Collaborated with quality assurance teams to ensure all aspects of the study adhered to strict regulatory guidelines at every stage.
  • Assisted with database upgrades and migrations by performing user acceptance testing. (move this to Provantis SIL role??)
  • Created data management plans and provided input on study designs.

Education

Bachelor of Science - Biology

Plymouth State College
Plymouth
05.1998

Skills

  • GLP Knowledge
  • Change Control
  • Validation Protocols
  • Computer system validation
  • Teamwork and Collaboration
  • Problem-Solving
  • Time Management
  • Attention to Detail
  • CAPA Management
  • Equipment Qualification
  • Data Integrity
  • Validation Testing

Certification

ALAT

Hobbies: Fishing, Boxing, Taekwondo

I am an avid bass angler in my free time.  I also enjoy boxing and Taekwondo.  

Timeline

Validation Specialist

Charles River Laboratories
01.2008 - 09.2024

Manager of Technical Operations

Charles River Laboratories
01.2008 - 04.2018

Study Supervisor

Charles River Laboratories
01.2004 - 01.2008

Bachelor of Science - Biology

Plymouth State College

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Laura Lis