Federica Caruso
Ruswil
Summary
Multilingual Biology Laboratory Technician with progressive experience in the GMP Quality Control field. Effectively communicates in both written and verbal form and works efficiently and accurately. Experienced in the Pharmaceutical Industry as well as academic environment.
Overview
13
13
years of professional experience
Work History
Microbiology Lab Technician
MSD Merck Sharp & Dohme AG
Schachen, LU
09.2022 - Current
- Performed water and environmental monitoring in classified production areas.
- Performed endotoxin testing, both routine and suitability, with 96-well plates and cartridges for methods KTA and KCA.
- Performed bioburden and suitability testing.
- Created many different templates and worksheets for different analyses.
- Contributed to SOP updates beyond core responsibilities to support process improvements.
- Worked on a global scale to harmonize processes.
- Worked on different studies, both GMP and non-GMP.
- Maintained up-to-date GMP documentation in a dynamic environment with frequent system and procedural changes.
- Worked on improving the sterility testing process, thanks to previous extensive experience with isolators and different methods of sterility testing.
- Proactively improved sampling plans using GIMP, enhancing visual clarity and lab usability through a modular and easily updatable design.
- Worked on making GMP processes more efficient through knowledge of the processes and the programs used for documentation.
- I gave constructive feedback whenever possible in order to always improve the working environment.
- Participated in company events as an active member.
QC Senior Analyst
Cilag AG - Janssen farmaceutical companies of Johnson & Johnson
Schaffhausen
05.2019 - 08.2022
- Conducted sterility testing on many injectable products, with methods such as filtration and direct inoculation, as well as sterile subcultivation.
- Built expertise with the use and maintenance of old and new H2O2 Glove-Box Isolators.
- Conducted LAL testing for endotoxin detection.
- Conducted Bioburden testing for many different products.
- Conducted water analysis on different kinds of water, such as WFI, purified water and raw water, as well as disinfectants such as Dismozon and Melsept.
- Conducted biological indicators testing with steel discs and paper stripes of Geobacillus stearotermophilus.
- Recorded, reported and posted results in LIMS company software.
- Worked successfully under major stress conditions while being alone during late shift, maintaining communication with the production and delivering the results in time
- Motivated and encouraged team members to communicate more openly and constructively with each other.
- Demonstrated leadership by making improvements to work processes and helping to train others.
- Executed lab investigations due to lab non conformances and provided documentation
QC Microbiology Lab Technician
IBSA - Institute Biochimique SA
Lamone And Massagno
08.2012 - 07.2015
- Apprenticeship performed in both a sterile and non sterile laboratories
- Conducted Water filtration and sampling
- Environmental monitoring in the production and in the lab
- Responsible for culture media preparation and autoclave of lab tools in stericlin bags
- Conducted microorganism identifications with the VITEK2 and Gram coloration
- Conducted medium growth controls with different microorganisms
- Conducted sterile product testing such as cremes and pills
Education
Biotechnology
ZHAW Zurich University of Applied Sciences
Wädenswil, Switzerland02.2019
Apprenticeship As Biology Lab Technician
SPAI Scuola Professionale Artigianale Industriale
Trevano, TI, CH07.2015
Skills
- GMP documentation practices
- Lab non-conformance detection, documentation, communication, and investigation
- SOP updates
- Lab work templates' creation and updates
- Computer skills: MS Office, Moda, ELN, eShopfloor, GIMP, surface knowledge of Procal, SP PM, Veeva Vault, and eVal, among many others
- Sterile and non-sterile product testing
- Water and environmental monitoring
- Bioindicators testing
- LAL testing for endotoxin detection, KTA, and KCA
- Bioburden testing on many different products
- Microorganism identification with Microseq and VITEK-2
- Expertise in the use of different sterile H2O2 isolators, and maintenance
- Sterility Testing: membrane filtration and direct inoculation as well as subcultivation
- Sterilization Procedures and use of different disinfectants such as Melsept, H2O2, Incidin, Isopropyl Alcohol
- Friendly, positive attitude
- Solution oriented
- Flexible team worker
- Work Ethic: facing towards diversity and inclusion and high quality working environment
Languages
Italian
First Language
English
Proficient
C2
German
Advanced
C1
French
Intermediate
B1
Spanish
Elementary
A2
Affiliations
- Scouting experience: Over 20 years of involvement in scouting, demonstrating leadership, teamwork, resilience and community engagement
- Scout leader of Scout Gambarogno, scouting since 2002, and leader since 2014
- Head of the Diversity and Inclusion team in a cantonal scout organization for four years
- Troop leader heads for the World Scout Jamboree in South Korea in 2023
- Cantonal scout expert for pioneering
- G+S camping, sports, and trekking
- Participate in and lead courses for other scout leaders
- Other:
- Poledance instructor
- Very creative hobbies such as 3D printing, cosplay/costume making, body painting, technology and engineering, and programming
Timeline
Microbiology Lab Technician
MSD Merck Sharp & Dohme AG
09.2022 - Current
QC Senior Analyst
Cilag AG - Janssen farmaceutical companies of Johnson & Johnson
05.2019 - 08.2022
QC Microbiology Lab Technician
IBSA - Institute Biochimique SA
08.2012 - 07.2015
Biotechnology
ZHAW Zurich University of Applied Sciences
Apprenticeship As Biology Lab Technician
SPAI Scuola Professionale Artigianale Industriale
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