Summary
Overview
Work History
Education
Skills
Timeline
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Marina Austin

Haverhill,MA

Summary

Forward-thinking candidate bringing 4 years of expertise in quality within the pharmaceutical manufacturing industry. Excels in cultivating rapport with individuals to optimize project goals and output, resolving complex problems, and delivering innovative improvement strategies. Proficient in quality management software and conducting investigations with a dedication to the highest standard of quality and patient safety.

Overview

5
5
years of professional experience

Work History

Quality Control Microbiologist

Bausch & Lomb
07.2023 - Current
  • Perform antibiotic microbial assay testing, per USP 81.
  • Manage batch release and quality metrics.
  • Issue and carrying out laboratory investigation records for OOT/OOS results.
  • Manage and organize test schedules for a team of 4, ensuring efficient use of time and resources.
  • Train new employees in various GMP activities.
  • Department lead for 5S projects, performing internal audits for continuous improvement efforts.
  • Spearheaded the design of a user requirement specification (URS) for microbial assay, backing the company's transition from paper to an electronic data system.
  • Active participant in regulatory audits, demonstrating SME knowledge of local procedures, documentation, and adherence to established guidelines.

QC Analyst, Microbiologist

Lonza Biologics
11.2021 - 07.2023
  • Performed routine endotoxin, bioburden, and total organic carbon testing for in-process, lot release, and stability studies utilizing Standard operating procedures.
  • Meticulously reviewed and approved electronic and paper documentation for on-time performance of batch release.
  • Carried out job functions with an owner mentality, executing tasks with the highest standard of quality and regulatory compliance.
  • Actively participated in audits from federal regulatory agencies and customers.
  • Completed Lean Six Sigma Yellow Belt certification.
  • Executed quarterly and annual maintenance on laboratory analyzers and equipment.

Surgical Assistant

Oral Surgery Associates
06.2020 - 11.2021
  • Assisted surgeons in invasive oral procedures with the use of anesthesia.
  • Triaged patients in a fast-paced three-surgeon office before procedures utilizing knowledge of pharmaceuticals and common illnesses.
  • Adhered to strict sanitation protocols and record-keeping up to Joint Commission standards.
  • Adaptable and proficient in learning new concepts quickly and efficiently.

Education

Bachelor of Science - Microbiology

The University of Maine
Orono, ME
05.2020

Skills

  • Good Manufacturing Practice (GMP)
  • Good Laboratory Practice (GLP)
  • Knowledgeable in 21 CFR part 11
  • Microsoft Suites
  • Quality Management Software (QMS)
  • Laboratory Information Management Systems (LIMS)
  • Technical Writing
  • Equipment Maintenance/Calibration
  • Data Management

Timeline

Quality Control Microbiologist

Bausch & Lomb
07.2023 - Current

QC Analyst, Microbiologist

Lonza Biologics
11.2021 - 07.2023

Surgical Assistant

Oral Surgery Associates
06.2020 - 11.2021

Bachelor of Science - Microbiology

The University of Maine

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Marina Austin