QC Analyst I (EM)

bioMerieux Inc.; Durham (NC); Sur place; USD 32 000 - 44 000; Plein temps

Avantages offerts par ce poste

Medical, dental, and vision plans

Life Insurance

Disability Insurance

Retirement Plan

Adoption Assistance

Wellness Programs

Employee Assistance Program

Commuter Benefits

Voluntary benefit offerings

Discount programs

Parental leaves

Résumé du poste

bioMerieux Inc. is seeking a QC Analyst I (EM) in Durham, NC to perform routine Environmental Monitoring testing on materials and products, ensuring accurate documentation and adherence to GDP and SOPs.

The role emphasizes foundational QC knowledge, collaboration with cross-functional teams, and contributing to process improvements and investigations while maintaining regulatory compliance and instrument upkeep.

Qualifications

• 3+ years of experience in Environmental Monitoring or Microbiology with GxP testing in a regulated environment (FDA, ISO, USDA).
• Experience with LIMS data entry and analysis; GMP/GLP knowledge preferred.
• Familiarity with GDP, SOPs, and regulatory requirements; strong organizational and communication skills.

Responsabilités

• Perform routine QC Environmental Monitoring testing on raw materials, finished products, air, water, surface, personnel, and cleaning samples with accurate documentation per SOPs.
• Review laboratory testing against SOPs, specifications, and timelines.
• Maintain compliance with SOPs, GLP, GMP, and HSE requirements; support QC procedures development and implementation.
• Prepare laboratory areas for regulatory, customer, and internal audits, including review of logbooks, calibration records, expirations, and cleanliness.
• Maintain laboratory instruments and upkeep; support material inventory and quality reports.
• Assist in investigations by documenting invalid results and supporting root-cause analysis.
• Collaborate with site teams to track project deliverables and communicate issues to management.
• Enter and maintain data in LIMS and paper records; support system upkeep and validation activities.

Connaissances

Environmental Monitoring

Microbiology

GxP Testing

Documentation

Regulatory Compliance

Lab Safety

Formation

High School Diploma

Outils

LIMS

MS Office

Description du poste

QC Analyst I (EM)

QC Environmental Monitoring

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 thoery 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.

Primary Duties

• Perform routine QC Environmental Moniroting testing (e.g., bioburden, conducitivity, 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 rootcause 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 paperbased records, supporting system upkeep and validation activities.
• Maintain current training on departmental processes and appropriately use PPE for routine and nonroutine 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 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, ect.) preferred.

Preferred Qualifications

• 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.

Education

• High School Diploma, GED or equivalent required.

Key Skills, Knowledge, and Abilities

• Acting with Honor and Being Open: Consistently upholds and reflects the core ethical principles and values that bioMerieux promotes.
• Communicating Effectively: Written Communications - including the ability to communicate technical data in written form.
• Communicating Effectively: Effective verbal communication skills.
• Getting Organized: Practicing time management to allocate tasks, balance priorities, and meet deadlines efficiently.
• Maintaining Focus: Thriving in a fast-paced environment by managing tasks, multitasking, and adapting quickly to maintain productivity.
• Managing Work Processes: Collect and analyze data to drive informed decision-making to improve performance and identify issues.
• MS Office: 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 and 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% of time.
• International travel required: 0% of time.

The hourly pay for this role in the state of North Carolina is between $23 and $32.20. This role is eligible to receive a variable annual bonus based on company, team, and individual performance per bioMerieux'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.

• *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

BioMerieux Inc. and its affiliates are Equal Opportunity/Affirmative Action Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information. Please be advised that the receipt of satisfactory responses to reference requests and the provision of satisfactory proof of an applicant's identity and legal authorization to work in the United States are required of all new hires. Any misrepresentation, falsification, or material omission may result in the failure to receive an offer, the retraction of an offer, or if already hired, dismissal. If you are a qualified individual with a disability, you may request a reasonable accommodation in BioMerieux's or its affiliates' application process by contacting us via telephone at [phone], by email at [email protected], or by dialing 711 for access to Telecommunications Relay Services (TRS).