Stefanie Kaiser
Eagan,MN
Summary
Strong leader and problem-solver dedicated to upholding top-level quality and compliance while streamlining operations to decrease costs and promote organizational efficiency. Uses independent decision-making skills and sound judgment to positively impact company success and provide a high-quality product to customers.
Overview
11
11
years of professional experience
Work History
Associate Director, Quality Assurance
Wuxi AppTec (now Part of NAMSA)
03.2022 - Current
- Lead Quality Assurance and Quality Systems teams to ensure site compliance and drive improvement.
- Create/monitor/report team metrics.
- Lead CAPA review board and management review.
- Lead/host all regulatory inspections (FDA, EMA, TGA, AATB) and accreditation assessments (ISO 17025 and ISO 13485).
- Support client audits, internal audits, and supplier audits.
- Track and address client complaints and SCARs.
- Review, revise, and approve quality agreements.
- Manage the activities of managers, supervisors, and individual contributors.
- Contribute to overall operations and to the achievement of departmental and site goals, including TAT, OTD, and product quality.
- Oversee annual budget planning processes, ensuring financial goals are met while maintaining optimal resource allocation across teams.
- Collaborated with senior leadership in managing all aspects of operations and site initiatives.
Manager, Quality Assurance
WuXi AppTec
03.2019 - 03.2022
- Oversight of the Quality Assurance (QA) team, who perform audits and applicable document reviews for GLP and GMP studies.
- Ensured systems in place maintain compliance to GLP, GMP and/or applicable ISO standards.
- Monitored and maintained standard operating procedures for adherence to regulatory requirements.
- Developed, implemented and approved policies and procedures.
- Reviewed, approved, and performed investigations.
- Provided guidance for non-compliance situations using creative problem solving skills.
- Responsible for the hiring, transfer, promotion, discharge and salary changes of staff.
- Participated/lead continuous improvement initiatives both within QA and cross functionally.
Sr. Quality Systems Validation Specialist
WuXi AppTec
10.2018 - 03.2022
- Provided quality oversight for software validation, equipment qualifications and technology transfers.
- Drafted and executed protocols and validations in accordance to cGMP and internal procedures.
- Executed Gap Analysis and/or Risk Assessments to ensure evaluation of critical systems and equipment were in compliance with all applicable regulatory requirements.
- Assessed suppliers for technical and quality capabilities utilizing a risk-based approach.
- Hosted client, regulatory and internal audits.
- Change control and CAPA ownership and review.
- Reviewed and approved deviations, master validation plans, and SOPs.
- Ensured data integrity following 21 CFR Part 11 compliance with automated systems and databases.
Validation Specialist
WuXi AppTec
12.2015 - 10.2018
- Drafted, reviewed and executed validation protocols- IQ/OQ/PQ in accordance to cGMPs and internal procedures.
- Reviewed periodic evaluations of equipment to maintain compliance to GMP, GLP and ISO requirements.
- Maintained the equipment and software periodic review schedule and inventory list.
- Provided guidance for failure analysis, risk assessment, root cause and corrective action determination.
- In depth knowledge of 21 CFR Part 11 facility and equipment automated systems and databases.
- Authored and reviewed SOPs
- Assisted with client audits and regulatory inspections
Associate Quality Assurance Specialist
WuXi AppTec
01.2015 - 12.2015
- Ensured study compliance to applicable FDA and ISO requirements by performing in-lab inspections, data review, and final report/certificate audit.
- Assisted with review and approval of quality system documents.
- Assisted in identifying, initiating and/or reviewing QA CAPA activities (deviations, lab investigations, OOS).
- Assisted with internal department audits as requested.
- Performed lab reviews and other QC review activities.
R&D Analytical Chemistry Intern
Nestle HealthScience
10.2013 - 12.2014
- Performed physical and chemical tests (pH, viscosity, osmolality, gravity flow, physical, etc.) on nutritional beverages and tube feed products in accordance with GLP to ensure quality control.
- Assisted researchers with bench work, observations, and visual characterizations for products in various stages of development.
- Assisted with observations, visual characterizations, sensory evaluation, and data analysis/recording/review.
- Performed calibration, maintenance and daily/weekly/monthly checks on laboratory equipment.
- Composed work instructions and internal control plans for correct usage and maintenance of new laboratory equipment.
- Validated equipment and laboratory instructions before implementation.
Education
Bachelor of Arts - Biology, Chemistry
The College of Saint Scholastica
Duluth, Minnesota05.2012
Skills
- GLP- FDA, OECD
- GMP- FDA, EMA, TGA
- ISO 17025 and ISO 13485
- Strategic leadership
- Team development
- Conflict management
- Customer service
- Crisis intervention
- LIMS, MasterControl
- SIMCO, REES
2021 Exceptional Employee Award
Recognized for "outstanding performance and exceptional commitment to teamwork".
Timeline
Associate Director, Quality Assurance
Wuxi AppTec (now Part of NAMSA)
03.2022 - Current
Manager, Quality Assurance
WuXi AppTec
03.2019 - 03.2022
Sr. Quality Systems Validation Specialist
WuXi AppTec
10.2018 - 03.2022
Validation Specialist
WuXi AppTec
12.2015 - 10.2018
Associate Quality Assurance Specialist
WuXi AppTec
01.2015 - 12.2015
R&D Analytical Chemistry Intern
Nestle HealthScience
10.2013 - 12.2014
Bachelor of Arts - Biology, Chemistry
The College of Saint Scholastica
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