Lead Quality Technician

Lesaffre North AmericaWest Goshen Township, PA
Onsite

About The Position

The Lead Quality Technician will perform quality control testing on raw materials, in-process samples, and finished microbial products to ensure compliance with specifications. This role involves reviewing and analyzing test results, performing various microbiological techniques, and maintaining laboratory data. The technician will also assist in investigations, participate in team meetings, and contribute to the improvement of laboratory systems and safety. Additionally, they will support Quality Assurance activities and other departments as needed, while maintaining a clean and safe laboratory environment.

Requirements

  • Experience with microbiological testing, including serial dilutions, plating techniques, and bacterial enumeration.
  • Strong understanding of aseptic techniques and microbiological laboratory practices.
  • Experience with environmental monitoring in controlled or aseptic environments.
  • Strong organizational skills with the ability to manage multiple priorities.
  • Ability to analyze data, troubleshoot issues, and make sound decisions.
  • Effective verbal and written communication skills.
  • Ability to work independently and collaboratively within a team environment.
  • Detail-oriented, dependable, and committed to quality and safety.
  • Proficient in Microsoft Office applications, including Excel, Word, and Outlook.
  • Ability to perform basic mathematical calculations, including addition, subtraction, multiplication, and division using whole numbers, fractions, and decimals.
  • Ability to calculate rates, ratios, percentages, dilutions, and concentrations, and interpret laboratory data, charts, and graphs.
  • Ability to apply sound judgment and common sense in carrying out written and verbal instructions.
  • Ability to analyze laboratory data, identify potential issues, troubleshoot problems, and make decisions based on established procedures and quality requirements.

Nice To Haves

  • Experience working in a GMP-regulated environment preferred.
  • Experience in microbial fermentation, industrial microbiology, or biotechnology manufacturing is a plus.
  • Experience with laboratory information systems, quality management systems, or electronic documentation systems is preferred.

Responsibilities

  • Perform quality control testing on raw materials, in-process samples, and finished microbial products to ensure compliance with specifications.
  • Review and analyze test results and communicate any out-of-specification or unusual findings to the appropriate personnel.
  • Perform microbial enumeration using serial dilution, plating, and other microbiological techniques.
  • Conduct industrial inoculations, including flask assembly, inoculation, purity verification, and cell count activities.
  • Prepare microbiological media and perform shake flask preparation and processing.
  • Coordinate and schedule shake flask preparation and delivery to support production inoculations.
  • Perform cryo streaking, purity streaking, culture maintenance, and inoculation activities.
  • Accurately record laboratory data, test results, and observations in a timely manner.
  • Assist in investigating laboratory deviations, nonconformances, and quality issues.
  • Participate in team meetings and provide updates on laboratory activities, testing results, and culture progress.
  • Follow approved procedures and actively participate in the creation, review, revision, and implementation of SOPs, work instructions, and quality documentation.
  • Identify opportunities to improve laboratory safety, efficiency, and quality systems.
  • Support Quality Assurance activities, including internal audits, training, and document review.
  • Maintain organized laboratory records and provide historical data when requested.
  • Assist other departments as needed to support business operations.
  • Maintain a clean, safe, and organized laboratory environment.
  • Support safety programs, participate in safety initiatives, and perform routine safety inspections.
  • May provide guidance and training to new or junior laboratory personnel.
  • Other duties as assigned.
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