QC Lead Analyst (EM)

BioFire Diagnostics; Durham (NC); On-site; USD 59,000 - 88,000; Full time

Benefits offered by this job

Medical, dental & vision plans

Retirement plan with employer match

Wellness programs

Commuter benefits

Employee Assistance Program

Job summary

bioMérieux is seeking a QC Lead Analyst (Environmental Monitoring) to lead the Environmental Monitoring team, oversee testing of materials and products, and drive regulatory compliance and data integrity in a fast-paced FDA-regulated environment.

The role requires a Bachelor’s in Life Sciences or equivalent experience, strong GMP/GLP knowledge, and leadership skills to mentor staff and manage investigations and audits.

Qualifications

• Bachelor degree or 4 years of relevant experience in a regulated lab environment.
• Experience in environmental monitoring or microbiology labs with GxP testing.
• Strong knowledge of GMP/GLP principles and regulatory audits (FDA, ISO, OSHA, etc.).
• Ability to lead, mentor, and develop staff and to manage multiple priorities.

Responsibilities

• Provide front-line leadership for the QC Environmental Monitoring team and manage daily scheduling.
• Develop, mentor, and train staff to achieve high performance and growth.
• Oversee routine Environmental Monitoring testing and ensure regulatory compliance and accurate documentation.
• Manage laboratory operations including testing requests, inventory, and instrument maintenance.
• Ensure GDP-compliant documentation and data integrity across all QC activities.
• Lead or support high-complexity investigations (OOS, NC, CI, CAPA) and aid audits.
• Recommend SOP revisions, support data trending, and maintain calibrated systems.

Skills

GxP testing

Environmental Monitoring

Leadership

Regulatory knowledge

SOP writing

LIMS

Data integrity

Audits

Mentoring

Education

Bachelor's degree in Life Sciences

Tools

LIMS

MS Office

Job description

QC Lead Analyst (EM)

Position Summary

The Quality Control (QC) Environmental Monitoring Lead Analyst provides front-line leadership for the QC Environmental Monitoring team performing routine testing of raw materials, intermediates, finished goods, and stability samples. The role oversees and may execute testing while ensuring regulatory compliance, accurate documentation, and proper use of validated and calibrated instrumentation. The Lead Analyst applies advanced analytical and regulatory expertise to optimize methods and lead high-complexity OOS, NC, CI, and CAPA investigations.

They are responsible for developing employees, managing projects, maintaining laboratory operations, driving accountability for team performance, and leading quality initiatives that improve testing processes. This position enhances departmental productivity, efficiency, testing quality, and culture by identifying inefficiencies, adapting workflows, and collaborating across the organization to drive productivity and continuous improvement.

Primary Duties

• Provides front-line leadership for the QC Environmental Monitoring team, serving as backup to the QC Manager and overseeing daily scheduling, shift meetings, accountability for team performance, and Quality decisions.
• Develops, mentors and trains, and motivates employees to achieve high performance, foster internal growth, and maintain alignment with current QC processes and procedures.
• Oversees and may execute routine 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 regulatory compliance and accurate documentation from the QC Environmental Monitoring team.
• Manages laboratory operations, including scheduling special testing requests, inventory, and ensuring proper use, maintenance, and troubleshooting of validated and calibrated instrumentation.
• Ensures all testing documentation is thorough, timely, and GDP-compliant, and maintains high standards of data integrity across all QC activities.
• Leads or oversees high-complexity investigations, including OOS, NC, CI, and CAPA, and supports audits as a subject matter expert using advanced analytical and regulatory knowledge.
• Recommends and authors SOP revisions and process improvements, supports data trending and LIMS data entry, maintenance, and review, and ensures team training remains current and compliant with departmental requirements.
• Enforces safety policies, ensures proper PPE use, and maintains a clean, organized, and cGLP-compliant audit-ready laboratory environment.
• Drives continuous improvement by identifying inefficiencies, adapting workflows, and participating in cross-functional initiatives to enhance productivity, efficiency, testing quality, and departmental culture.
• Supports departmental goal setting, validation activities, and other duties assigned by management to maintain operational readiness and quality standards.
• Perform all work in compliance with company quality procedures and standards.
• Perform other duties as assigned.

Qualifications

Required Qualifications

• Bachelor degree required in Biology, Microbiology, Chemistry, Biochemistry, or other life science discipline.
• Education Substitution: In lieu of a Bachelor's degree, 4 years of additional relevant experience, defined below, will be accepted
• 4+ years of professional related experience in lieu of degree:
  • Experience working in a regulated Environmental Monitoring or Microbiology laboratory (e.g., FDA, ISO, USDA, etc.) performing GxP testing.
  • Related experience includes conducting Quality Control laboratory testing and analysis in a regulated environment, including analytical testing, laboratory investigations, method troubleshooting, equipment qualification, data review, technical documentation, and training and mentoring of laboratory personnel.

Preferred Qualifications

• Proven technical and scientific knowledge working with relevant Environmental Monitoring and/or Microbiology laboratory techniques and quality principles (GMP/GLP) preferred.
• Demonstrates strong knowledge of domestic and international regulations and industry standards (ISO, QSR, UL, CSA, VDE) and has experience supporting regulatory audits such as FDA, MDSAP, ISO, OSHA, and EPA.
• Extensive experience in the use of software tools for data entry and analysis (LIMS); advanced technical writing skills.
• Shows strong organizational, leadership, and interpersonal abilities including training and developing staff, prioritizing multiple tasks, planning testing schedules, collaborating across levels, and authoring/editing SOPs.
• Exhibits advanced analytical, problem-solving, documentation, and investigation skills, including data trending, report preparation, GDP compliance, and effective verbal and written communication.
• 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, lead improvement initiatives, assess safety and environmental risks, and independently problem-solve and provide solutions with minimal supervision.
• Experience working in a regulated Environmental Monitoring or Microbiology laboratory (e.g., FDA, ISO, USDA, etc.) performing GxP testing. Related experience includes conducting Quality Control laboratory testing and analysis in a regulated environment, including analytical testing, laboratory investigations, method troubleshooting, equipment qualification, data review, technical documentation, and training and mentoring of laboratory personnel is strongly preferred.
• Experience coordinating laboratory activities, assigning work, training employees, leading projects, or serving as a technical resource and mentor to other analysts is strongly preferred.

Education

• Bachelor degree required.
• Preferred field(s) of study:
  • Biology
  • Microbiology
  • Chemistry
  • Biochemistry
  • Other life science discipline
• In lieu of a Bachelor's degree, 4 years of additional relevant experience will be accepted.

Key Skills (Knowledge, Skills, and 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 Presentation Skills, including the ability to present technical data.
• Leading without authority through influence and guidance of others towards a common goal by using expertise, persuasion, and personal qualities to inspire action.
• Managing and measuring work by tracking progress, performance, and goal achievement using metrics and KPIs.
• Inspire and energize individuals to achieve their best performance.
• Skilled in MS Office tools, including but not limited to Outlook, Teams, Word, and Excel.
• Expert: leads in applying technology; innovates, optimizes processes, and trains others.

Working Conditions & 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 adjust or move objects up to 50 pounds in all directions.
• Domestic travel required: 0%.
• International travel required: 0%.

Work Environment

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

The annual pay for this role in the state of North Carolina is between $58,700 and $88,000. This role is eligible to receive a variable annual bonus based on company, team, and individual performance per bioMérieux’s bonus program. This range may differ from ranges offered for similar positions elsewhere in the country given differences in cost of living. Actual compensation within this range is determined based on the successful candidate’s experience and will be presented in writing at the time of the offer.

In addition, bioMérieux offers a competitive Total Rewards package that may include:

• 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 programsParental leaves