Summary
Overview
Work History
Education
Skills
Timeline
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Nicolas Childers

Oxnard

Summary

Dedicated quality technician well-versed in overseeing complete planning, trend modeling and documentation. Several years of experience providing detailed communications regarding necessary quality assurance processes and priorities. Pivotal statistical analysis and tracking to maintain and archive specific data-test results. Thorough approach to logging performance details to bolster qc considerations.

Overview

16
16
years of professional experience

Work History

Quality Technician

Avita Medical LLC
Ventura
12.2019 - 07.2025
  • Enforced FDA and ISO policies for Medical Device standards and cGMP compliance.
  • Conducted incoming inspections of raw materials to ensure quality compliance.
  • Performed in-process inspections on components and finished goods to maintain standards.
  • Executed final inspections and product release processes for quality assurance.
  • Evaluated Device History Records and sterilization documentation, including dose audits and lab testing.
  • Managed new customer complaint system, investigating feedback through internal and external processes.
  • Certified as ISO 13485:2016 Auditor, enhancing compliance oversight.
  • Certified IPC J-STD-001 Specialist, ensuring high standards in electronic assembly processes.

Quality Analyst

Amgen Inc.
Thousand Oaks
02.2019 - 11.2019
  • Maintained up to Grade 5 ISO clean rooms or environments to ensure all regulatory cGMPs are met in accordance with internal SOPs.
  • Viable and nonviable sampling of clean room environments.
  • Daily collection of samples by means of agar collection of air particulates or surface sampling.
  • Initiate Identify and schedule resampling when CFU’s are observed above internal parameters.
  • Maintain cross department interaction in regard to individual sampling schedule, passing or failing results when alert action responses are triggered.
  • Maintain a clean room aseptic standard when sampling to ensure no cross contamination in a highly dynamic environment.
  • Data collection and electronic input for all viable and nonviable samples taken on site

Quality Inspector

Hygiena LLC
Camarillo
06.2015 - 03.2018
  • Adhered to and enforced all policies regarding standard operating procedures (SOPs) and current good manufacturing practices (cGMPs)
  • Cross-department verification of product and components regarding start up procedures
  • Investigate all possible dimensional infidelities and when observed, compiles data to justify a return to vendor procedure.
  • Research potential bottlenecks through understanding cross department procedures to streamline operations and Quality respectively
  • Insured quality of product and safety of all personnel was never compromised
  • Maintained interaction with all corresponding vendors when specification for product was not met
  • Maintained a clean room standard during inspections to ensure minimal to no cross contamination.

Quality Inspector

Golden State Medical Supply
Camarillo
01.2010 - 02.2015
  • Adhered to and enforced all FDA pharmaceutical policies regarding standard operating procedures (SOPs) and current good manufacturing process (cGMPs).
  • Prevented potential recalls on three separate occasions
  • Called for the recall of incorrect Batch Records
  • Re-evaluated procedure to prevent cross-contamination
  • Implemented safety incentives within warehouse to minimize health risks
  • Researched pictograms for product label in accordance with industry standards
  • Researched potential bottlenecks through understanding of cross-department procedures
  • Cross-department verification of product and components regarding BR for release
  • Insured quality of product and safety of all personnel was never compromised
  • Investigated all potential discrepancies found

Education

Associate of Arts - Music

Ventura College
Ventura, CA

Skills

  • Detail-oriented professional with over a decade of experience in both the biotech industry and warehouse operations; highly self-motivated with a strong commitment to expanding knowledge and advancing career growth in a collaborative team environment

Timeline

Quality Technician

Avita Medical LLC
12.2019 - 07.2025

Quality Analyst

Amgen Inc.
02.2019 - 11.2019

Quality Inspector

Hygiena LLC
06.2015 - 03.2018

Quality Inspector

Golden State Medical Supply
01.2010 - 02.2015

Associate of Arts - Music

Ventura College

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Nicolas Childers