QC Analyst 1

bioMérieux•Durham, NC

8d•$23 - $32•Onsite

About The Position

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. The position collaborates with internal teams, contributes to process improvements, and helps generate and track project deliverables.

Requirements

3+ years of experience working in a regulated Environmental Monitoring or Microbiology laboratory (e.g., FDA, ISO, USDA, etc.) required, with GxP testing preferred.
Technical and scientific knowledge working with relevant 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/Environmental Monitoring testing, knowledge of USP and EP/BP method/validation regulations preferred.
Demonstrates strong organization, prioritization, independent task management, and the ability to read, understand, and execute SOPs while assessing safety and environmental risks.
Communicates effectively in both verbal and written forms and works collaboratively with teams.
Troubleshoots and solves problems with supervision as needed, providing practical solutions when issues arise.
High School Diploma, GED or equivalent.
Skilled in MS Office tools to include but not limited to Outlook, Teams, Word, and Excel.
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 adjust or move objects up to 50 pounds in all directions.

Nice To Haves

GxP testing preferred.
Technical and scientific knowledge working with relevant 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/Environmental Monitoring testing, knowledge of USP and EP/BP method/validation regulations preferred.

Responsibilities

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.
Perform all work in compliance with company quality procedures and standards.
Perform other duties as assigned.

Benefits

A choice of medical (including prescription), dental, and vision plans providing nationwide coverage and telemedicine options
Company-Provided Life and Accidental Death Insurance
Short and Long-Term Disability Insurance
Retirement Plan including a generous non-discretionary employer contribution and employer match.
Adoption Assistance
Wellness Programs
Employee Assistance Program
Commuter Benefits
Various voluntary benefit offerings
Discount programs
Parental leaves