KATHY CEPEDA
Orlando
Summary
Highly organized and dedicated Manufacturing/Validation Associate, and business owner with over 18 years of customer service experience. Strong background in biotech and pharmaceutical environments. Experienced with managing business operations, leading teams, and driving strategic initiatives. Utilizes expertise in financial oversight and process optimization to enhance business performance. Track record of fostering team collaboration and achieving operational excellence.
Excellent communication skills in both English and Spanish, and proficiency in Microsoft Office. Additional experience in warehouse shipping and receiving.
Overview
19
19
years of professional experience
Work History
Business Manager
Yesha Y Seged
Kissimmee, FL
03.2024 - Current
- Managed daily operations to ensure efficient workflow and optimal team performance.
- Developed and implemented process improvements, enhancing service delivery and client satisfaction.
- Conducted market research to inform strategic planning and enhance competitive positioning.
- Analyzed financial reports to identify cost-saving opportunities and drive budgetary compliance.
Validation Consultant
Organogenesis
Canton, MA
02.2023 - 10.2023
- Conducted validation studies for medical devices to ensure compliance with regulatory standards.
- Developed and executed validation protocols, ensuring accurate documentation of results.
- Collaborated with cross-functional teams to address quality issues and implement process improvements.
- Reviewed and revised standard operating procedures to enhance consistency in validation processes.
Validation Consultant
Pfizer
Andover, MA
12.2021 - 12.2022
- ·Conduct validation for manufacturing systems, equipment, or software to ensure that they meet operational and regulatory requirements.
- Execution of IOPQ, PQ, RQ and Final Report for all Equipment validation Temperature Mapping.
- Analyzed data trends from validation tests to identify areas for process optimization.
- Led root cause analysis meetings to resolve non-conformances and improve operational efficiency.
- Prepared comprehensive reports detailing findings and recommendations for stakeholders' review.
Validation Consultant
Uniqure
Lexington, MA
02.2021 - 11.2021
- Execution of IOPQ, PQ, RQ and Final Report for all Equipment validation Temperature Mapping.
- Investigate validation execution failures and provide impact justification for deviations.
- Operate Data-Tracer and Kaye Validator 2000 for protocol execution.
- Maintain CQV test equipment in current validated state.
- Conduct validation for manufacturing systems, equipment, or software to ensure that they meet operational and regulatory requirements.
Associate II, Validation
Brammer Bio, Thermo Fisher Scientific
Cambridge, MA
01.2017 - 12.2020
- Generate, execute and close-out commissioning test plans and/or validation protocols required as part of change control.
- Oversee CQV revalidation program for the site.
- Proficient in Equipment validation, and RCM Validation.
- Operate Data-Tracer and Kaye Validator 2000 for protocol execution. Kneat advance user.
- Assess change controls and perform validation impact assessments. Manage resources to complete validation protocol execution activities.
- Conduct validation for manufacturing systems, equipment, or software to ensure that they meet operational and regulatory requirements.
Manufacturing Associate IV
Biogen
Cambridgde, MA
06.2007 - 12.2016
- Operated manufacturing equipment following strict safety protocols and standard operating procedures.
- Conducted quality inspections to ensure compliance with product specifications and regulatory standards.
- Collaborated with team members to optimize production workflows and enhance operational efficiency.
- Trained new associates on equipment use, safety measures, and quality control processes.
Education
Associate of Arts - Business
Bunker Hill Community College
Charlestown, MA05-2022
Skills
- Financial management
- Customer service
- Project management
- Employee management
- Issue resolution
- Sales and marketing
- Business administration
- Cross-functional collaboration
- Risk assessment and management
Languages
English
Full Professional
Spanish
Native or Bilingual
Timeline
Business Manager
Yesha Y Seged
03.2024 - Current
Validation Consultant
Organogenesis
02.2023 - 10.2023
Validation Consultant
Pfizer
12.2021 - 12.2022
Validation Consultant
Uniqure
02.2021 - 11.2021
Associate II, Validation
Brammer Bio, Thermo Fisher Scientific
01.2017 - 12.2020
Manufacturing Associate IV
Biogen
06.2007 - 12.2016
Associate of Arts - Business
Bunker Hill Community College