Jennifer Fonseca Soto
Cayey
Summary
Self- Starter, Leader and Project Manager with experience within the Pharmaceutical/ Biotechnology Industries. Experience developing and implementing production/processing methods and controls meeting quality standards in the most cost efficient manner. Experience with cGMP Systems, GMP, Leadership, project management and risk management analysis. Known for reliability and adaptability, with swift capacity to learn and apply new skills. Committed to leveraging these qualities to drive team success and contribute to organizational growth.
Overview
10
10
years of professional experience
Work History
Associate Manufacturing- AML 6 Cell Culture
AMGEN
08.2020 - Current
- Inoculate bioreactors and transfer Media and solutions (insulin, cysteine additions to support daily activities
- Take, analyze and approve samples on different equipments as CEDEX, CEDEX BIO, BGA, YSI and NOVA
- Review production records and testing results to certified that the documentation is accurate, and detailed according to written procedures, cGMP, and requirements, including electronic batch records and logbooks
- Documentation and approve different kind of samples as PH, LAL and conductivity
- Participate of internal plant audits
- Engage in Continuous Improvement initiatives, programs and projects as a 6S Champion
- Managed time efficiently in order to complete all tasks within deadlines.
- Used critical thinking to break down problems, evaluate solutions and make decisions.
Sr. Associate Manufacturing
Kelly Services (AMGEN)
03.2020 - 08.2020
- Purification Area Drug Substance : Enbrel, Dmab, Repatha, Aranesp, Epogen
- Perform Clean In Place, Pressure Test and Steam In Place operations
- Performed Analytical Tests as Protein Concentration, PH, Conductivity, LAL
- Use software as EBR, LIMS and PCS
- Preparatory, Process and Post Process activities to support Chromatography Skids (Pro A, HA, TMAE), Viral Inactivation, Viral Filtration and UF/DF – In training
IPT Operator
Merck
01.2018 - 01.2020
- Perform visual inspections, approval of major and minor cleanups, and Set Ups when required
- Regularly draft and revise routine documents(e.g
- MPs, SOP’s, and technical reports)
- Perform and collaborate in validation protocols, coating, mixing, dispensing activities, special samplings, and physical tests, among others complying with standard operating procedures (SOP) and Good Manufacturing Practices (CGMP's), good documentation and safety practices
- Provide troubleshooting support or assist in the evaluation of atypical events in the manufacturing area
- Assist with the execution of the process validation
- Generate and received inventory orders on SAP
- Operated various types of machinery, demonstrating versatility and adaptability in diverse work environments.
Manufacturing Associate
Kelly Services (Amgen-AML 14- Formulation and Filling Finish)
01.2015 - 01.2018
- Hands-on operations, set-up, clean, sanitize and prepare room and equipment for the Filling and Formulation Process
- Assist in the review of documentation for assigned functions
- Leadership and guidance for the team
- Train staff to perform hand-on tasks
- Using aseptic techniques to prepare assemble and sterilized special equipment use in parenteral processes and take samples to assure integrity of the equipment
- Use and perform equipment as: Autoclaves, Part Washers, Filter Integrity testers, Ultra Sonics, Stoppers Tanks equipments, etc
- Evaluate, plan, and implement solutions for process improvement opportunities
- Execute routine validation protocols
- Approve Manufacturing orders to assist QA activities
Education
Master in Project Management -
University of Turabo
Gurabo, PR01.2017
Certification of Quality Inspector -
Job Center
Caguas, PR01.2016
Bachelor of Sciences - Biology
Universiy of Puerto Rico
Cayey, PR01.2014
Skills
- Project Management
- Logistics
- Pressure Handler
- LIMS/LMS/WERUM/SAP/EBR/ PCS
- Microsoft Office Suite
- Quality Systems
- Lean Six Sigma
- SOP / cGMP’s
- 5 Why’s/ Root Cause Analysis
- Process Improvement
- Leadership
- Problem-solving/Providing solutions
- Basic understanding of analytical methods
- Friendly, positive attitude
- Teamwork and collaboration
Knowledge And Skills
- Project Management (Basic Troubleshooting, Planning, Cost Reductions, Logistics, Schedules, Pressure Handler)
- IT/Automation (LIMS, LMS, WERUM, SAP, EBR, Microsoft Office Suite (Word, Excel, PowerPoint), Cognos, PCS and SPSS)
- Quality Systems (Lean Six Sigma, SOP’s, cGMP’s, 5 Why’s, Root Cause Analysis, Process Improvement and CAPA)
- Fully Bilingual, excellent communication skills (oral and written)
- Leadership, Team Work, Ability to communicate and follow assignments through to completion, statistical mathematical skills, proven skills in problem solving and providing solutions, basic understanding of analytical methods used in support of facility process monitoring
Languages
English
Spanish
Timeline
Associate Manufacturing- AML 6 Cell Culture
AMGEN
08.2020 - Current
Sr. Associate Manufacturing
Kelly Services (AMGEN)
03.2020 - 08.2020
IPT Operator
Merck
01.2018 - 01.2020
Manufacturing Associate
Kelly Services (Amgen-AML 14- Formulation and Filling Finish)
01.2015 - 01.2018
Bachelor of Sciences - Biology
Universiy of Puerto Rico
Master in Project Management -
University of Turabo
Certification of Quality Inspector -
Job Center
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