Warehouse Operations Clean Room
Resume:
STEVE SOTELO
Sunland CA 91040
OBJECTIVE: Seeking a challenging position with responsibility and expectations
with advancement opportunities. Applying all my skills to meet deadlines and challenges with teamwork and commitment and be part of a successful firm.
QUALIFICATIONS: Pharmaceutical Technician: SME on operations, safety, and training for proper cleaning of equipment. Aseptic qualification for gowning and cleaning ISO 5 manufacturing areas. Troubleshooting and follow cGMP and SOP closely and carefully as required per FDA in clean room environment. Set up labeling machine and package finished product. Inspect labels prior to start up for confirmation. Enter Lot/expiration dates and confirm artwork is correct. Pay close attention to details. Place sample label on batch record.
Operate Delta V, Web handling, Validations and challenge runs. Work in teams or individually, meet deadlines and troubleshoot equipment when necessary.
Separate defects and submit to MRB. Monitor critical data on operations and document. Perform hourly checks and reconciliations. Revise SOP’s as needed. Excellent communication skills with coworkers and management. NC owner and initiator access. Warehouse operations as needed for materials and finished products. Backup Supervisor/Scheduler set up priorities and changeovers. Take advantage of training opportunities offered to gain knowledge and growth. Computer trained with Word, Excel, and PowerPoint. Type 45wpm. Excellent attendance record. Very responsible and accountable.
Computer skills, excel, word,PowerPoint, data collection, Microsoft outlook, inventory status.
EDUCATION: CAL Lutheran University 2007 (Undergraduate studies) Business Management
WEST VALLEY OCCUPATIONAL (2001)
Beginning Electronics
WORK HISTORY:
Thermo fisher scientific
West hills ( 07/2020-present)
Senior site specialists
Make gel electrophoresis for and assist scientists, restock materials. Hazardous waste management. Create buffers using laboratory equipment including pipetts, syringes, scales and vortex. Safety awareness team, PPE knowledge and verification during procedures. Communicate any safety concerns during team meetings. Database entries throughout the day. Place material orders using SAP, calibrate Luminex equipment change sheath fluids.
Software specialists contractor
Amgen Thousand Oaks ( 12/2019-07/2020)
Packaging technician/ Labeler
Operate labeler to apply on finished goods. Perform room clearances prior to starting lots using MES to verifiy materials,expirations and quantities. Use SAP to issue production kits and to confirm incoming materials. Perform batch record review after lot is completed and store in cold rooms for shipment.
NantKwest Culver City ( 5/18-12/19)
Cell Culture Technician II
Operate cell culture equipment in sterile environment. Set up for vial thaw and place in incubator, media preparation,count cells for VCD ( viable cell density) on NC 200 Nucleocounter and check PH on Nova Flex. Monitor Xuri Bioreactors using Unicorn for temperature, DO, PH, rocking angle and speed. Check daily and post expansions for cell growth. Setup XDR 50 and Ksep for harvest days in ISO 5 environment.
Aseptic cleaning around BSC and plating after operations. Transfer cells to irradiation and then to BSC for bag filling and place in cassettes. Transfer to cryo room and connect LN2 tanks for cryofreeze operations and transfer to freezers for shipment.
Axia pharma Westwood (6/17- 5/18) Lead Manufacturing tech
Operate Penntech line for production of prescription vials. ISO 5 level operations, aseptic technique throughout process. Inventory, autoclave, batch record review.
Room cleanings, ordering kits, solutions, gowning supplies. Perform plating and air monitoring in operation areas.
Gilead (real staffing) San Dimas / La Vern (7/16- 5/17) Manufacturing tech ll
Room and equipment aseptic cleanings, autoclave, startocheck operations.
Packaging line operator. Assist with
Validation start up, and commissioning. SAT for packaging line at new facility in La Vern
Aeroteck agency (7/15 to 6/16) Dukes aerospace Canoga Park. Expeditor for Honda aircraft parts. Operate vibe table for valves.
Kit materials for manufacturing associates. Inspect for damage, expiration, quantity and verify lot numbers. Inventory for in house products. KanBan reorder materials and parts as needed
Grifols Operator I
City of Industry (8/14-7/15)
Operate packaging line for finished product, adjust Optel camera system, Senel system for China product verifications, reload cartoner, adjust printing jets, perform change overs, line clearance verifications, monthly PM’s, move finished products to warehouse department.
Pharmavite Packaging Line Lead
Valencia (04/14-8/14)
Operate packaging lines producing vitamins and medications for overseas and domestic contracts. Perform changeovers, operate Optel camera systems, change labels, submit samples, cleanroom checks and reconciliations. Monitor operations and enter quantities and downtimes and any issues onto computer. Perform inventories every other month.
Dendreon Sr. Materials Handler/Manufacturing associate Seal Beach (07/11-01/14)
Clean room environment ISO 5, ISO 7, and ISO 8, Follow cGMP, SOPs, GDP’s, Aseptic technique qualified. Review batch records, department safety representative. Ensure PPE is being used, record review and initiate work orders using Oracle. Attend department meetings.
Adjust materials, verify and transfer Antigen, separation containers, syringes, and other required items into production area using FIFO/FEFO Oracle system. Complete kits for processes production lots. Receive and acknowledge incoming Apheresis
and complete transaction into Oracle. Verify transactions are competed for
pickups from couriers. Return unused labels back to warehouse. Perform inventory for warehouse and reorder according to Kanban levels.
Operate centrifuge inside workstations and follow Batch Record to finish first part of process and set inside incubators. Review completed batch records using EBR.
First FDA approved immunotherapy facilities with a 99% delivery to patient success rate.
Baxter Bioscience Technician III, Los Angeles (02/08- 07/11)
Cleanroom environment, operate CIP and COP with Delta V to clean tanks, transfer panels and parts. Trouble shoots issue with equipment. Enter samples submissions using aseptic technique into LIMS for Lab support. Department safety representative, ensure all PPE’s are being used. Follow cGMP, SOP’s and GDP’s.
Documenting UI’s (user interventions) reports and POMR
(Process operation monitoring reports) SOP revisions. Class 1000 -10000 clean room environment.
Operate Centrifugation, Filter Presses and harvest after completion. Weigh drums and enter results into Delta V, place onto pallets and into -75c freezers.
Generate work orders and close out, scale standardizations.
Buffer prep assistance and transfer panel and jumper cleanings.
AMGEN Process Technician IV, Thousand Oaks (2005-2007)
Cleanroom environment. Class 1000-10000 Purification Process support.in Clinical and Commercial. Operate CIP and SIP skids to clean tanks and transfer panels. Troubleshoot issues with equipment.
Autoclave parts and log into log books, verify log book entries are correct.
Preparations for use of sanitized and sterilized tanks and other
equipment for processes. Carefully follow all cGMP and SOP’s closely.
Safety representative for department, ensure PPE’s are being used.
Revise SOP’s, work with engineering for upgrades on current equipment, work overtime as needed and shift changes for department needs. Inventory on materials and order when needed, refill solutions daily, monitor usage. Generate
NC’s and close out as needed. Take samples aseptically and enter into LIMS
Paying close attention to detail
COMMUNITY
INVOLVEMENTS: VOLUNTEER/ MENTOR: Jeopardy Center at risk youth program city of Pacoima
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