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Augustbioservices1mo ago
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Quality Control Lead, Microbiology

United StatesUnited States·NashvilleFull-Timelead
OtherQuality Control
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Quick Summary

Overview

Reporting to the Supervisor, Microbiology, the Quality Control Lead operates independently to perform biological assays of raw materials, in-process samples, finished product,

Technical Tools
OtherQuality Control
Reporting to the Supervisor, Microbiology, the Quality Control Lead operates independently to perform biological assays of raw materials, in-process samples, finished product, and environmental monitoring samples. They will represent microbiology leadership on the third shift to ensure that all testing for in-process, finished product, raw materials and stability samples is completed in a timely manner. They will also coordinate with cross-functional teams to support filling and environmental monitoring activities.
  • Act as a subject matter expert for microbiology and compliance, supporting deviation investigations, CAPA implementation, and technical audits
  • Review and approve microbiological testing records for accuracy and adherence to test methods instrument malfunctions, and methodology problems
  • Represent the microbiology department on relevant cross-functional teams to help improve processes throughout the facility
  • Perform microbiological assays including sterility, endotoxin, bioburden, AET, biological indicator enumeration and growth promotion testing
  • Support routine and fill-related environmental, personnel and utility monitoring
  • Assist in the development and implementation of training programs that govern general and microbiological specific laboratory practices
  • Lead and participate in continuous improvement projects in the laboratory including 5S and inventory management
  • Bachelor’s degree (U.S. or foreign equivalent) in Biology or a related field.
  • 5-7 years of pharmaceutical experience
  • Ability to lead, train and mentor analysts in microbiological assays
  • Ability to work in a fast-paced environment with minimal supervision
  • Able to work flexible schedules at short notice
  • Experience with EMPQs and Aseptic Process Simulations
  • Familiarity with QMS systems such as Master Control and BMRAM
  • Working knowledge of cGMP, FDA, ICH, USP, and other regional and country specific guidance
  • Proficient in Microsoft Word, Excel, Outlook, and PowerPoint
  • Prolonged periods sitting at a desk and working on a computer.
  • Must be able to lift up to 15 pounds at times

    • Location & Eligibility

    Where is the job
    Nashville, United States
    On-site at the office
    Who can apply
    US

    Listing Details

    Posted
    July 22, 2026
    First seen
    July 22, 2026
    Last seen
    August 4, 2026

    Posting Health

    Days active
    0
    Repost count
    0
    Trust Level
    60%
    Scored at
    July 22, 2026

    Signal breakdown

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