QC Analyst I (EM)

BioFire Diagnostics, LLC; Durham (NC); Presencial; USD 32 000 - 44 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Medical insurance

Retirement plan

Wellness programs

Commuter benefits

Resumo da oferta

BioFire Diagnostics, LLC seeks a QC Analyst I (EM) to perform routine Environmental Monitoring testing on materials, products, and environmental samples, ensuring accurate documentation and adherence to GDP and SOPs. The role supports investigations and process improvements while maintaining lab instruments and participating in audits.

Candidate should have 3+ years in Environmental Monitoring or Microbiology with GxP exposure and be proficient with data entry in LIMS and MS Office.

Qualificações

• 3+ years in Environmental Monitoring or Microbiology with GxP in a regulated environment.
• Experience with LIMS data entry and analysis software.
• Knowledge of GDP/GLP/GMP and SOPs.

Responsabilidades

• Perform routine QC Environmental Monitoring testing on materials and products with accurate documentation.
• Review laboratory testing per SOPs, specifications, and timelines.
• Maintain compliance with SOPs, GLP, GMP, and HSE requirements.
• Prepare laboratories for audits by reviewing logs and calibration records.
• Enter and maintain data in LIMS and paper records.
• Assist investigations and root-cause analyses.
• Collaborate with site teams to track deliverables.

Conhecimentos

Environmental Monitoring

GxP Testing

SOP Adherence

Data Entry

Formação académica

High School Diploma

Ferramentas

LIMS

MS Office

Descrição da oferta de emprego

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 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.

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 bioMérieux 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 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 programs
• Parental leaves

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