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bioMérieux

Global in vitro diagnostics for infectious diseases

QC Analyst 1 - Environmental Monitoring

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-timeDurham, NC, USAIn-person

About the Job

Requirements

  • At least 3 years of experience working in an Environmental Monitoring or Microbiology laboratory.
  • High school diploma, GED, or equivalent.
  • Technical and scientific knowledge of relevant laboratory techniques and quality principles, including GMP and GLP.
  • Experience using software tools for data entry and analysis, including LIMS.
  • Experience with QC or Environmental Monitoring testing and knowledge of USP and EP/BP method and validation regulations.
  • Ability to organize and prioritize work, manage tasks independently, and read, understand, and execute SOPs while assessing safety and environmental risks.
  • Ability to communicate technical data in writing and communicate effectively verbally.
  • Ability to troubleshoot and solve problems with supervision as needed, providing practical solutions.
  • Working knowledge of MS Office tools, including Outlook, Teams, Word, and Excel.
  • Ability to remain stationary, sitting or standing, for prolonged periods; ascend and descend stairs, ladders, ramps, and similar structures; correctly wear PPE most of the day; and move objects up to 50 pounds in all directions.
  • Legal authorization to work in the United States is required for all new hires.

Responsibilities

  • Perform routine QC Environmental Monitoring testing, including bioburden, conductivity, and total organic carbon analysis, on raw materials, finished products, and air, water, surface, personnel, and cleaning samples; ensure accurate, thorough, and timely documentation in compliance with GDP and established protocols.
  • Review laboratory testing in alignment with SOPs, specifications, and required timelines.
  • Maintain compliance with SOPs, GLP, GMP, and HSE requirements, and support development and implementation of QC procedures.
  • Prepare laboratory areas for regulatory, customer, and internal audits, including review of logbooks, calibration records, expirations, and cleanliness.
  • Maintain laboratory instruments and laboratory upkeep, support material inventory maintenance, and contribute to quality assessments, reports, and documentation.
  • Assist in investigations by documenting invalid results, supporting root-cause activities, and applying foundational scientific theory.
  • Collaborate with team members and site groups to track project deliverables and communicate issues to management.
  • Enter and maintain data in LIMS and paper-based records, supporting system upkeep and validation activities.
  • Maintain current training on departmental processes and appropriately use PPE for routine and non-routine laboratory work.
  • Participate in continuous improvement and 6S efforts and perform additional duties assigned by management.
  • Perform all work in compliance with company quality procedures and standards.
  • Perform other duties as assigned.

Desired Qualifications

  • Experience with GxP testing in a regulated environment, such as FDA, ISO, or USDA.
  • Technical and scientific knowledge of relevant laboratory techniques and quality principles, including GMP and GLP.
  • Experience using software tools for data entry and analysis, including LIMS; advanced technical writing skills.
  • Experience with QC or Environmental Monitoring testing and knowledge of USP and EP/BP method and validation regulations.

About the Company

bioMérieux

Global in vitro diagnostics for infectious diseases

bioMérieux provides medical diagnostics worldwide by developing, manufacturing, and selling diagnostic tests, instruments, and software that detect infectious diseases and antimicrobial resistance. Its products work by analyzing patient samples through diagnostic assays and integrated systems that combine reagents, specialized instruments, and software to produce actionable test results for healthcare providers, laboratories, and public health agencies. The company stands out from competitors through its global leadership in in vitro diagnostics, a broad portfolio of instruments, reagents, and software, and a strong emphasis on public health and antimicrobial resistance challenges. Its goal is to improve patient care and public health by delivering timely, accurate diagnoses that help guide treatment and curb the spread of infectious diseases.

Company size
5,001-10,000
Company stage
IPO
Headquarters
Marcy-l'Étoile, France
Founded
1963

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