Analyst II – Quality Control (QC) Environmental Monitoring

Position Summary

The Quality Control (QC) Environmental Monitoring Analyst II is an individual contributor responsible for overseeing and executing QC testing, ensuring accurate documentation, regulatory compliance, and proper instrument validation and function. The role applies comprehensive analytical and regulatory knowledge to the design and optimization of methods, and leading complex OOS and NC investigations. Working independently, the Analyst II facilitates team communication, assists in training staff, and influences practices by clearly explaining policies, facts, and procedures as an SME. The position also contributes to process improvements by identifying inefficiencies, adapting work methods, and collaborating across the organization to drive alignment and problem-solving.

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 revisions to QC procedures and SOPs through the change control process.
• Prepare laboratory areas for regulatory, customer, and internal audits, including review of logbooks, calibration records, expirations, and cleanliness.
• Maintain and troubleshoot laboratory instruments, laboratory upkeep, maintain material inventory, and prepare quality assessments, reports, and documentation.
• Lead complex OOS and NC investigations using root-cause analysis, and applying comprehensive analytical knowledge.
• Collaborate with team members and cross-functional groups at the site to complete and track project deliverables, communicate issues to management, and assist with validation protocols for equipment and software.
• Enter and maintain data in LIMS and paper-based records, supporting system upkeep and validation activities.
• Maintain current training on departmental processes, act as a certified trainer to train staff on testing, and appropriately utilize PPE for routine and non-routine laboratory work.
• Participate in continuous improvement and 6S efforts while performing additional duties assigned by management.
• Perform all work in compliance with company quality procedures and standards.
• Perform other duties as assigned.

Qualifications

Required Education, Training and Experience

• High School Diploma, GED or equivalent.
• 4 years of related experience working in a regulated Environmental Monitoring or Microbiology laboratory (e.g., FDA, ISO, USDA, etc.) with GxP testing.

Preferred Education, Training and Experience

• Technical and scientific knowledge working with relevant Environmental Monitoring and/or Microbiology laboratory techniques and quality principles (GMP/GLP) preferred.
• Experience in the use of software tools for data entry and analysis (LIMS); advanced technical writing skills preferred.
• Experience with QC testing, in-depth knowledge of and experience applying relevant Domestic and International Regulations and Industry Standards (e.g. ISO, QSR, UL, CSA, VDE, etc.).
• Experience supporting regulatory audits (FDA, MDSAP, ISO, OSHA, EPA) and troubleshooting applicable laboratory instrumentation.
• Strong organizational, communication, and leadership skills with the ability to prioritize work, manage multiple tasks independently, and effectively collaborate in team-oriented environments.
• Proven ability to interpret, execute, and update SOPs, assess safety and environmental risks, and independently problem-solve and provide solutions with minimal supervision.

Key Skills (Knowledge, Skills & Abilities)

• Consistently upholds and reflects the core ethical principles and values that bioMérieux promotes.
• Written Communications - including the ability to communicate technical data in written form.
• Effective verbal communication skills.
• Understand complex information and interpret it accurately, often requiring critical thinking and analysis to grasp the full picture.
• Critical thinking, using logic and reason to analyze information and make decisions in the workplace.
• Driving continuous improvement by evaluating processes and implementing necessary changes.
• Skilled in MS Office tools to include but not limited to Outlook, Teams, Word, and Excel.
  • Intermediate: applies skills independently in most situations; handles moderately complex tasks with occasional guidance.

Working Conditions & Physical Requirements

Physical Requirements

• Ability to remain in stationary position, either sitting or standing, for prolonged periods.
• Ability to ascend/descend stairs, ladders, ramps, and the like.
• Ability to wear PPE correctly most of the day.
• Ability to operate heavy machinery. No
• Ability to adjust or move objects up to 50 pounds in all directions.

Travel Requirements

• Domestic travel required: 0%
• International travel required: 0%
• Total travel required: 0%

Additional Position Information

• This position is in a fast-paced, FDA regulated environment in the Medical Devices/Diagnostics Industry.
• The QC Environmental Monitoring Analyst II is a key position in the Environmental Monitoring laboratory, which performs testing of bioburden, environmental sampling/testing of water, surface, air, personnel, and cleaning.

Supervisory Responsibilities

• Direct supervision: 0 (Not applicable)
• Indirect supervision: 0 (Not applicable)