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QA/QC Specialist - 1801082

๐Ÿ”ฌ Position: QA/QC Specialist

๐Ÿ“ Location: Winchester, KY, USA

๐Ÿข Work Environment: Onsite with availability for irregular shifts


Position Overview:

Join our cutting-edge facility as a QA/QC Specialist, playing a pivotal entry-level role. This position demands the application of manufacturing and laboratory expertise, involving hands-on lab work, computer operations, and meticulous record-keeping. Focus on quality analysis and testing in a cleanroom environment adhering to cGMPs and SOPs.


Experience and Education:

  • ๐ŸŽ“ Associate Degree or Bachelor's in Science with 2 years in Laboratory and Manufacturing cleanroom environments.
  • ๐Ÿ–ฅ๏ธ Proficiency in Microsoft Excel and Word.
  • ๐Ÿ‘๏ธโ€๐Ÿ—จ Strong attention to detail.
  • ๐Ÿ“˜ Familiarity with Good Manufacturing Practices (cGMPs).
  • ๐Ÿ”ฌ Ability to apply basic scientific and regulatory principles.
  • ๐ŸŒ LIMS or MODA experience is a plus.
  • ๐Ÿ•ฐ๏ธ Availability for off-hours or weekend work.


Key Responsibilities:

  • ๐Ÿงช Test utilities such as USP water, clean steam, and other manufacturing environments.
  • ๐Ÿ—๏ธ Support the QC department following the procedures.
  • ๐Ÿ“ˆ Utilize MODA for data entry, compilation, and environmental trend analysis.
  • ๐Ÿค Collaborate with Manufacturing and QA for routine EM, changeover EM, and monitoring.
  • ๐Ÿงผ Perform media fills and fill/finish monitoring for air quality and aseptic techniques.
  • ๐Ÿ’ก Act as QC authority for aseptic flow and behavior within cleanrooms.
  • ๐Ÿ“Š Maintain flexibility to meet unique campaign requirements, including off-hour and weekend work.
  • ๐Ÿ“ Maintain accurate written records of all analyses performed.
  • ๐Ÿ“Š Accurately interpret and effectively communicate analytical results and issues.
  • ๐Ÿ—“๏ธ Schedule daily tasks in an organized and efficient manner.
  • ๐Ÿ”ฌ Demonstrate general knowledge of the use and operation of basic laboratory equipment.
  • ๐ŸŽ›๏ธ Calibrate and maintain lab equipment and instrumentation.
  • ๐ŸŒก๏ธ Operate in a safe manner, familiar with basic laboratory and chemical hygiene practices.
  • ๐Ÿ‘ฅ Work seamlessly in a team environment, contributing to a "flow to the work" approach.
  • ๐Ÿงผ Collaborate with other lab personnel to maintain a clean and safe work environment.
  • ๐Ÿ“‘ Perform peer review of analytical testing and contribute to report writing.
  • ๐Ÿ“„ Write SOPs on an as-needed basis.


Join us and contribute to the excellence of our operations! Apply now to be part of a team dedicated to maintaining high standards in quality control and manufacturing. ๐Ÿ” #QAQCSpecialist #QualityControl #ScienceCareers


Thank you. We will be in contact soon.

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