R D Manufacturing Operations

Alma Montoya

Wildomar, CA *****

Skills:

● cGMP, GDP, and SOP oriented

● Chemistry, chemical testing, and laboratory

● Excellent and effective verbal and written communication

● Operates automated instrumentation pipettes, centrifuges, Autoclave,Ph/Conductivity Tester

● Handle and dispose of chemicals

● Cleanroom environment

● Self-motivated and work well with minimal direction Professional Experience:

Argonaut Manufacturing Services

11/23 - 06/24

Pfizer

●Inspects and troubleshoots machines and equipment.Maintains cleanliness of areas and equipment

●Verifies expiration dates, part numbers, lot numbers, of components and Reagent Lyopellets

●Assembles test kit by inserting reagent pellets/beads, gaskets, wax, Lysis, aluminum heat conductor to the bottom chip chamber according to Engineering Batch Record Work Instructions

●Performs final inspection of complete assembled test kit

●Performs labeling and pouching with desiccants, sealing the pouch using Accuseal machine

●Packs the sealed and labeled pouches in the ziplock bag for shipping

●Documents and provides reports to Pfizer regarding completion including inventory R&D of Argonaut

Supports R&D with Demo and builds

SWAB ASSEMBLY:

● Performs dipping of swab stick in the Tween Solution and place it on the swab rack with holes to dry

● Inserts the dried swab with solution in the labeled pouch with desiccant and seals the pouch with Accuseal machine

● Performs final inspection of the sealed pouch

● Packs the inspected pouches in the ziplock bags and or boxes

● Documents and provides reports to the manager

TUBES ASSEMBLY:

● Fills tubes with Lyobeads using pick and place machine according to batch records work instructions

● Inspects beads quality and quantity in the tube

● Performs labeling of the tubes, pouching with desiccants and sealing of pouches with Accuseal machine

● Documents and provides reports to the manager

● Do other duties as assigned

Quidel Ortho

09/23 - 11/23

● Sub assembly of 2Sars Antigen, Sofia test kit by putting solutions on fabric on the reels using pumps, computers and Spotter Machine

● Calibrates accurate PH reading of formulas using pump machine

● Verifies documents for expiration date, part numbers and lot numbers, calibration dates of machines

● Final and visual Inspection of swab pouches, packaging of finished products Argonaut Manufacturing Services

02/23 - 04/23

●Performs various routine manufacturing tasks under the direction of internal SOPs and cGMP guidelines

●Prepares material components for manufacturing operations

● Documents steps clearly and completely in production batch records, logbooks, and other controlled forms

● Performs basic arithmetic and algebraic computation

● Maintains cleanliness of areas and equipment

● Performs bulk drug formulation using mixers, balances, ph meters, orbital mixer, vortex, centrifuge, pipettes including repeater, serological pipette, peristaltic pump, stir pale and heater plate

● Performs sterile filling of a multitude of solutions including drug products, media and buffers

● Performs kitting, packaging and labeling of tubes,bottles and boxes Biologics Manufacturing Associate 1, Abzena San Diego, CA 06/22 - 01/23

● Gowned in accordance with cGMP Class 10K and 100K cleanroom

● Responsible for specific product-related operations in protein purification

● Maintains production equipment with single-use materials as it relates to harvest and protein purification

● Autoclaves tubings and materials needed for cleanroom and laboratory

● Obtains and stock supplies as directed. Orders supplies to the material department through email

● Performs a variety of complex tasks in accordance with cGMP, cGDP, SOPs and Batch Records

● Reviews completed Production, Buffer and Purification batch records daily for cGMP compliance

● Performs basic arithmetic and algebraic computation

● Maintains cleanliness of areas and equipment, sanitizes Bio Safety Cabinet

● Maintains records to comply with regulatory requirements and assist with in-process testing including SoloVpe testing for accuracy and potency of the product

● Assembles tubings and filters in Biosafety Cabinet using aseptic techniques

● Aliquot with micropipettes samples of finished products in different kinds and sizes of tubes in Bio Safety Cabinet aseptic method for QA and QC and Lab Department

● Generates labels to be used for hand label solutions to be used for production, QA and QC

● Delivers samples to the laboratory and to the warehouse freezer room

● Collects and disposes wastes

● Performs other related duties as assigned

Assembler, Thermo Fisher Scientific, San Diego, CA 12/21 - 06/22

● Assemble cassettes for Accula Sars- Cov-2 Test

● Prebuilt cassettes and weld plastic cover using welder machine

● Place Mdst, RT, Amplification beads

● Seal complete product using bond sealer machine

Education:

Vocational Nursing Northwest College, Riverside, CA Phlebotomist Complete Phlebotomy Training, Hemet, CA Patient Care Assistant Technician Maric College, San Diego, CA Bachelor of Science in Commerce Columban College, Olongapo City, Philippines Certificates, Training and Accomplishments:

Vocational Nursing Diploma. • Home Health Aide Certificate • Certified Nursing Certificate • Phlebotomist Certificate CPR and First Aid Certificate

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