Dynamic and results-oriented people manager with extensive expertise in environmental compliance and strategic innovation. Proven success in leading cross-functional teams, facilitating FDA audits, and optimizing aseptic production environments to achieve operational excellence. Proficient in preventative and corrective action planning, with a track record of updating over 160 critical documents to align with evolving industry standards. Committed to driving continuous improvement initiatives and fostering a culture of compliance that enhances organizational integrity and performance.
Hi, I’m
Kelsie Stoszkus
Wentzville,MO
Summary
Overview
10
years of professional experience
Work History
Kindeva Drug Delivery
Microbiological Services Supervisor
01.2022 - Current
Job overview
- People Manager/Hiring Manager.
- Support FDA tours and audit requests as an SME.
- Support of bringing new Facility online.
- Technical writing with revisions of over 160 technical documents.
- Coordinated inventory management activities, optimizing stock levels and reducing waste.
- Responsible for record retention program and controlled copies with the environmental compliance lab.
- Quality observer over media fills with smoke study experience.
- Supervise daily operations, ensuring compliance with safety and quality standards.
- Engages with cross-functional teams as needed to support continuous improvement activities.
- Coordinates incident investigations, corrective and preventive actions.
- Manage quarterly and annual trend reports of environmental utility systems.
- Trained and mentored team members on operational procedures and best practices.
Pfizer Pharmaceuticals
Inspection Training and Qualification Specialist
01.2019 - 01.2022
Job overview
- Analyze and expedite training needs in a timely manner with individual testing of over 60 colleagues and 5 different testing processes.
- Support FDA audit requests as an SME.
- Perform a variety of studies to gather/maintain data for continued growth, method updates and process improvement.
- Collaborated with cross-functional teams to enhance project efficiency and effectiveness.
- Conducted audits of qualification submissions to over 100 colleagues every quarter, ensuring accuracy and adherence to protocols.
- Evaluated qualification documents and test kits to ensure compliance with regulatory standards.
Pfizer Pharmaceuticals
Quality Assurance II
01.2018 - 01.2019
Job overview
- Sample, inspect, and audit components, drug product containers, packaging and labeling according to approved written material specifications, engineering drawings, artwork, and specimen labeling.
- Performs in-process check-ins, line clearances and challenges on machinery for verifications.
- Monitors production centers to make sure a standard of quality is met by GMP documentation.
- Worked effectively in fast-paced environments.
PDC Laboratories
Project Manager
01.2018 - 01.2018
Job overview
- Review results and expedite reports to clients.
- Identified plans and resources required to meet project goals and objectives.
- Coordinated with clients to clarify requirements and manage expectations effectively.
PDC Laboratories
Sample Control Technician
01.2016 - 01.2018
Job overview
- Microbiologist lead
- Quality Control testing and corrective actions.
- Experience making and testing buffer solutions, cultures and other media to ensure quality of the product falls in desired testing limits.
- Experience weighing chemicals, calibrating meters, troubleshooting and Ph adjustments with an abundance of chemicals.
- Conducted routine maintenance and calibration on control instruments to maintain accuracy and reliability.
- Testing experience with wastewater bacteria, drinking water bacteria, metals, wet chemistry, and transformer oils.
Education
Colorado State UniversityAurora, CO
Master of Science from Organizational Leadership/Emphasis in Change Control Management and Strategic Innovation
01.2023
University Overview
McKendree UniversityLebanon, IL
Bachelor of Science from Environmental Studies
01.2015
University Overview
Skills
- Training and mentoring
- Goal oriented
- Staff management
- Attention to detail
- Decision-making
- Staff development
- Processes and procedures
- Operations management
Timeline
Microbiological Services Supervisor
Kindeva Drug Delivery
01.2022 - Current
Inspection Training and Qualification Specialist
Pfizer Pharmaceuticals
01.2019 - 01.2022
Quality Assurance II
Pfizer Pharmaceuticals
01.2018 - 01.2019
Project Manager
PDC Laboratories
01.2018 - 01.2018
Sample Control Technician
PDC Laboratories
01.2016 - 01.2018
Colorado State University
Master of Science from Organizational Leadership/Emphasis in Change Control Management and Strategic Innovation
McKendree University
Bachelor of Science from Environmental Studies
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