QC Analyst I (EM)
bioMérieux
Summary
The Quality Control (QC) Environmental Monitoring Analyst I is an individual contributor focused on performing routine Environmental Monitoring testing on raw materials, finished products, bioburden from air, water, surface, personnel, and cleaning samples, while ensuring accurate documentation and adherence to established standards and protocols. Work is closely supervised, with responsibilities centered on applying foundational QC knowledge and scientific theory to execute operational tasks, support investigations, and maintain laboratory instruments.
Job description
Position Summary
The Quality Control (QC) Environmental Monitoring Analyst I is an individual contributor focused on performing routine Environmental Monitoring testing on raw materials, finished products, bioburden from air, water, surface, personnel, and cleaning samples, while ensuring accurate documentation and adherence to established standards and protocols. Work is closely supervised, with responsibilities centered on applying foundational QC knowledge and scientific theory to execute operational tasks, support investigations, and maintain laboratory instruments.
Primary Duties
- Perform routine QC Environmental Monitoring testing (e.g., bioburden, conductivity, and total organic carbon analysis) on raw materials, finished products, and air, water, surface, personnel, and cleaning samples while ensuring 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, HSE requirements, and support the 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, laboratory upkeep, support maintenance of material inventory, 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 groups at the site 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 while performing additional duties assigned by management.
Qualifications
Required Qualifications: 3+ years of experience working in an Environmental Monitoring or Microbiology laboratory, with GxP testing in a regulated environment (e.g., FDA, ISO, USDA, etc.) preferred.
Preferred Qualifications: Technical and scientific knowledge working with relevant laboratory techniques and quality principles (GMP/GLP). Experience in the use of software tools for data entry and analysis (LIMS); advanced technical writing skills. Experience with QC/Environmental Monitoring testing, knowledge of USP and EP/BP method/validation regulations.
Education: High School Diploma, GED or equivalent required.
Requirements
- 3+ years of experience working in an Environmental Monitoring or Microbiology laboratory
- GxP testing experience in a regulated environment (e.g., FDA, ISO, USDA)
- High School Diploma, GED or equivalent
- Technical and scientific knowledge of relevant laboratory techniques and quality principles (GMP/GLP)
- Experience with software tools for data entry and analysis (LIMS)
- Advanced technical writing skills
- Experience with QC/Environmental Monitoring testing
- Knowledge of USP and EP/BP method/validation regulations
- Strong organization, prioritization, and independent task management
- Ability to read, understand, and execute SOPs
- Effective verbal and written communication skills
- Ability to troubleshoot and solve problems with supervision
- MS Office skills (Outlook, Teams, Word, Excel)
Benefits
- Medical, Dental & Vision
- Life & AD&D Insurance
- Short & Long-Term Disability
- 401(k) Matching
- Adoption Assistance
- Wellness Programs
- Employee Assistance Program
- Commuter Benefits
- Parental Leave
- Discount Programs
Company overview
bioMérieux is a world leader in the field of in vitro diagnostics, founded in 1963 as a family-owned company based in Marcy-l'Étoile, France. With over 10,000 employees spread across 45 countries and serving 160 countries through an extensive distribution network, the company specializes in developing innovative diagnostic solutions for both clinical and industrial applications. Their clinical diagnostics help healthcare professionals quickly identify pathologies and contamination sources, while their industrial solutions assist manufacturers in meeting stringent quality and safety standards for food and pharmaceutical products. bioMérieux focuses on three key areas of in vitro diagnostics: microbiology (where they are the world leader), immunoassays for high medical value tests, and molecular biology for syndromic diagnosis of infectious diseases. The company is particularly committed to combating antimicrobial resistance (AMR), with three-quarters of their R&D and 80% of their product portfolio dedicated to this critical public health challenge. They also provide comprehensive solutions for sepsis diagnosis and management, as well as diagnostic tools for acute non-infectious conditions like cardiovascular and kidney diseases.