Amanda Olea Email & Phone Number

Irvine, California, United States

•Managed the creation and editing of 18K+ Global Quality System Documents to support a $55.14 billion company with 100K+ employees, 40+ manufacturing facilities, and product distribution within 100 countries •Manage Global and Local Documentation Change Controls (DCCs) cross-functionally (operations, medical devices, quality)•Provides KPIs (key performance indicators) to help provide opportunities for improvement within report metrics for high volume and problem prone processes• Co-Authored and implemented a new Quality System Process to help ensure all 74 local/affiliate site documents are in compliance with Global System Documentation updates•Implemented company migration from Attache electronic data management system (EDMS) to One Vault EDMS (Veeva Vault)•Oversee compliance training of personnel for various projects and roles through multiple databases and dashboards

Chino, California, United States

• Manage archive, retention, and destruction of internal documentation from multiple databases.• Conduct periodic internal audit and report findings to management weekly• Create a list of corrective actions of all documentation and facility findings• Conducted review of sample batch records pre-production and post-production• Collect samples of incoming raw materials, incoming raw ingredients for QA and QC validation and verification• Collect production blend samples/resamples of all final product blends entering and exiting the facility for QA and QC validation and verification.• Collect samples of packaging material for validation•Labeling nutrients validation and verification• blender sterilization and allergen free verification• Managed and recorded employee compliance records to SOP/Forms/Templates/Work Instructions/CBTs• Managed and assigned training on newly released/revised internal quality system documentation`• Verify that all products meet the company’s specifications for safety and quality against SDS and CoA’s• Create/Update systems to better improve the efficiency and efficacy of all raw data for better retrieval and improvement in other departments• Initiate and execute documentation of deviations and CAPAs

Irwindale, Ca

•Oversee the ongoing progress of projects internationally, deliver timelines, and assign action items to achieve project deliverables• Prepare documentation to execute the build of components, subassemblies, and full catheters• Prepare V&V, Animal study, CF, DVT, and First in Man/Human Clinical work orders (WO’s)• Support the coordination, preparation, and implementation of controlled documents through Engineering Change Orders (ECO’s)• Request parts from 3rd party affiliates/ vendors to meet demands of drawing/component/assembly specification in accordance with device manufacturing build• Oversee labeling projects and update requirements for IFU’s and UM’s in accordance with regulatory bodies such as DEKRA

550 Monica Circle Corona Ca 92880

•Assess all incoming raw materials to ensure supplier compliance with specifications according to certificate of analysis (COA) and safety data sheets (SDS)• Test and inspect all products on assembly line to insure it meets customer specifications and requirements set by the standard operating procedure (SOP)• Document information from inspections and laboratory findings using good documentation practice (GDP)• Perform laboratory tests such as microbial growth testing, stability testing, viscosity, color, clarity against formulations• Investigate errors to identify needed improvements and relayed findings to management in compliance with good manufacturing practice (GMP)• Assisted management to implement new company policies to aid in company compliance

Masters Of Science In Life Applied Sciences

Certified Phlebotomy Technician, Phlebotomy Technician/Phlebotomist

Bachelor Of Arts (B.A.), Biology, Pre-Med

Activities and Societies: AMSALead dinners at the Ronald McDonald House in Loma Linda. Helped set up a walk for the families who had lost.