Lead Quality Technician

Duties and 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.
  
  
  

Qualifications:

• 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.
  
  
  

Education and/or Experience:

• Bachelor’s degree in Microbiology, Biology, Biotechnology, or a related life science field required.
• Minimum of 4–7 years of experience in a Quality Control, Microbiology, or laboratory environment.
• Experience working in a GMP-regulated environment preferred.
• Experience in microbial fermentation, industrial microbiology, or biotechnology manufacturing is a plus.
  
  
  

Language Skills: Ability to read and understand instructions, procedures, correspondence, and technical documents. Ability to write clear and concise reports, emails, and laboratory documentation. Ability to effectively communicate test results, observations, and quality-related information to individuals with varying levels of technical knowledge. Effectively present information in one-on-one and small group situations to customers, clients, and other employees of the organization.

Computer Skills: Proficient in Microsoft Office applications, including Excel, Word, and Outlook. Experience with laboratory information systems, quality management systems, or electronic documentation systems is preferred.

Mathematical Skills: 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.

Reasoning Ability: 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..

Supervisory Responsibilities: This position has no supervisory responsibilities.

Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employees is regularly required to stand, walk, climb, use hands to finger, handle, feel, and reach. The employee is occasionally required to sit and talk or hear. The employee must lift up to 50 pounds on a seldom basis. Specific vision abilities required by this job include close vision, color vision, peripheral vision, and ability to adjust focus.

Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly exposed to fumes or airborne particles and toxic or caustic chemicals. The employee is occasionally exposed to wet and/or humid conditions, moving mechanical parts, extreme cold, and risk of electrical shock. The noise level in the work environment is usually quiet.