Summary
Overview
Work History
Education
Skills
References
Timeline
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Ashley Orosco

Peyton,CO

Summary

Highly-motivated employee looking for a meaningful opportunity with a desire to take on new challenges. Strong work ethic, adaptability, attention to detail and exceptional interpersonal skills. Adept at working effectively unsupervised and quickly mastering new skills.

Overview

10
10
years of professional experience

Work History

QC Specialist II

Aliri Bioanalysis
Colorado Springs, CO
05.2022 - Current
  • Adhere to Aliri Bioanalysis SOP's to include review and editing to ensure documents are in compliance with current industry standards and regulations.
  • Adhere to documentation and filing standards.
  • Comply with Good Laboratory Practice and other applicable regulations.
  • Train laboratory operations employees on new and/or updated practices.
  • Work with internal customers to improve day-to-day operations.
  • Perform quality review of run folders, notebooks, data tables that are sent out externally to customers.
  • Perform quality review of laboratory logbooks to include equipment, reagents, chemicals.
  • Assist in the updates of the formal method of analysis documents.
  • Verify laboratory calculations for chemists.
  • Other duties as assigned

Chemist

BioanaBioanalysislysisAliri Bioanalysis
Colorado Springs, CO
01.2014 - 04.2022
  • Supports the FDA bioanalytical department with analytical method development, validation, and/or sample analysis
  • Performs routine extraction of analyte from biological samples for validation and sample analysis projects. Requires proper use of calibrators, controls, and internal standards. Properly uses analytical equipment to accomplish work objectives.
  • Performs routine instrument functions for bioanalytical analysis, including accurate placement/verification of sample vials and creating accurate sequence file. Applies advanced technologies (mass spectrometry, robotics, and automation, etc.) as directed by manager.
  • May perform initial reviews of analytical data for acceptability of calibration, control values, chromatography, and quantitative limits. Ensures all data meets appropriate acceptance criteria per study plans.
  • Prepares reagents, solutions, and quality control samples as needed to complete routine assignments.
  • Maintains equipment, lab benches, and hoods in a clean, organized fashion. Performs limited maintenance on advanced instrumentation, including tuning, calibrating, cleaning, etc. Documents maintenance, cleaning and calibration as required.
  • Follows all SOPs, safety and security polices, and prescribed GLP and bioanalytical division practices; use SOP manual as reference to support work performed. Completes all necessary paperwork related to job duties.
  • Effectively communicates with team members and management regarding work-related issues. Notifies appropriate management of problems or delays, potential hazards, instrument malfunction, or inventory shortages or discrepancies.
  • Participates in data management and report development. Supports Data Management Team by drafting and/or reviewing reports for technical accuracy.

Quality Assurance Coordinator

Folium Biosciences
Colorado Springs, CO
01.2019 - 10.2021
  • Ensured that all staff in production facilities followed all regulations and maintained strict quality and safety standards.
  • Various job duties included staff training and scheduling, monitoring production, conducting audits, resolving complaints, correcting issues, equipment troubleshooting, and writing reports.
  • Provided direction and guidance for the implementation and adherence of all quality programs at manufacturing facilities (contract and internal as applicable), warehouses, and raw material suppliers.
  • Maintained all quality-controlled documentation in accordance with established Document Control procedures including revision, issuance, and archival of documents.
  • Assisted in the writing and review of all change controls and deviations initiated internally or by any customer, and in the Corrective Action process, including review, trending, and continual adherence to all CAPAs related to quality.
  • Responsible to write, review, and revise SOPs, documents, and materials designed to support GMP and regulatory compliance (21 CFR Part 111, Dietary Supplements).

Education

Bachelor of Science - Biology

University of Colorado At Colorado Springs
Colorado Springs, CO
05-2010

Skills

  • Quality Control Data Compilation
  • Data Capture and Analysis
  • Audit Assistance
  • Standardized Testing Methodology

References

References available upon request.

Timeline

QC Specialist II

Aliri Bioanalysis
05.2022 - Current

Quality Assurance Coordinator

Folium Biosciences
01.2019 - 10.2021

Chemist

BioanaBioanalysislysisAliri Bioanalysis
01.2014 - 04.2022

Bachelor of Science - Biology

University of Colorado At Colorado Springs

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Ashley Orosco