1. LACOMBE2016
3207 Henderson Mill Rd Apt. C2 Atlanta, Ga. 30341 | bellaluv515@gmail.com | (510) 469-5907
OBJECTIVE To obtain a job in the Healthcare Industry that will challenge me and allow for
further development of my skillset. My career in Pharm-healthcare in International
manufacturing operations has given me a broad perspective of regulations and
guidelines. I maintained the highest levels of CGMP 's,SOP 's and FDA Standards.
I am able to work in a cross functional group to achieve a common goal. I believe
in flexibility and the right tool for the right job.
SKILLS & ABILITIES Leadership- I was a Sub- Supervisor for Day and Swing Shifts in Media and
Fermentation. A member of the Site Safety Team where we found resolutions for
site wide issues. Developed and Maintained Job Assessment Producers (JSA- Job
Safety Analysis/ JSBO- (Job Safety Behavioral Observation) Undated rFVIII FS
Database for the Senior Management Team. Wrote daily Reports for
Manufacturing. I was the OJT Trainer (On Job Training) for current, new and
corrective action procedures. Completed work orders in SAP. Set up Kanban/ 5
organization for our ordering system.
Validation Documentation *Wrote SOP for I20 Helium Gas Detector *
Preformed Testing of new equipment using the Valagenesis Date Base * Test
Electronic Batch Recording (EBR) in our Wyerm MES system* Trackwise user
Validation Equipment * Help commission and validate Pressure Transmitters
for Continuous Cell Separation System (CCS) * Help validate protocol for CCS
Cart setup and preparation * Designed Prototype for new Closed Manifold System
EVA Bagging(FS) * Test the cleaning validation MA SKID Transfer Line *
Participate in Process Qualification (PQ) for new building for KGPF Plant (KGPF-
Kogenate Plasma Free)
EXPERIENCE FERMENTATION/ CELL CULTURE at Bayer Healthcare,Berkeley,CA
2004- 2013
1. Tasks - * monitoring the parameters of the Fermenter i.e. oxygen levels,
pH, and Conductivity etc. * To start the Cell Separation Process.
2. Equipment- *YSI meter * UDF Hood (Unidirectional flow hood) * Cedex
(cell counter instrument) * Toledo Centrifuge * Sebra Heat Sealer *
Watson- Marlow pumps * DCS (Data Control System) * I to Sample all
Fermenters and clear Harvest. * To bag the Product after processing.
MEDIA Production Processing at Bayer Healthcare,Berkeley, CA 2000-
2004
1. Tasks- *I made Media, Bulk Solutions and Insulin. * Pre Weighing
chemicals, Carbonate and Bicarbonate. *Process monitored Filtration to

2. PAGE 2
the end of process. *SAP Knowledge required to GI (Good Issue) * Sterile
Filters and Pre Filters.
2. Equipment- *I had to setup and assemble pre and sterile filters * I
performed CIP’ s and SIP ‘s (clean/ steam in place) of Tanks and
equipment * I performed pH, Conductivity, and TOS readings.
EDUCATION Graduated from John F. Kennedy High, college at Diablo Valley Community
College