QC Microbiology Analyst 1

Manufacturing Durham, North Carolina

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Description

Position Summary & Responsibilities:
Normal working hours for this role are Monday - Friday from 9:00am - 5:00pm although subject to change. 
The QC Microbiology Analyst 1 role is responsible for routine Microbiology testing – this includes the preparation and testing of finished product samples, stability samples, and special test requests per standard operating procedures; culture and manipulation of microbes using aseptic technique and other microbiological testing protocols; and documentation, contributions to Continuous Improvement initiatives, and investigational writing. This position is in a fast-paced, FDA regulated environment in the Medical Devices/Diagnostics Industry. The QC Microbiology Analyst 1 will be in a key position in the QC Microbiology laboratory performing testing for Growth Performance, Antimicrobial Neutralization, and Contamination Checks.
 
  • Quality:
    • Ensures all testing is completely documented in an accurate, thorough, and timely manner in compliance with procedures and GDP requirements.
    • Ensures review of laboratory testing is done in compliance with SOPs and is completed in a timely manner.
    • Maintains compliance with SOPs, GLP, GMP, and HSE requirements.
    • Prepares for regulatory, customer, and internal audits of Microbiology laboratory areas.
    • Preparation includes review of logbooks, instrument calibration dates, material expirations, and general cleanliness of laboratory area.
    • Provides input for laboratory investigations and documents invalid test results in compliance with procedures.
  • Documentation/Training:
    • Enters data into the laboratory information management system (LIMS) and applicable paper-based data sheets. Assists with LIMS data entry to support LIMS maintenance and validation activities.
    • Ensures personal training on current department processes and procedures is maintained.
  • Safety: Appropriately utilizes PPE (Personal Protective Equipment) as required to perform routine and non-routine laboratory duties.
  • Continuous Improvement:
    • Participate in continuous improvement activities.
    • 6S: Maintain the laboratory and other specific testing areas of responsibility in a well-organized, clean, and tidy manner in compliance with cGLP.
  • Performs additional job-related duties as assigned by management.
Education, Skills, & Experience:
  • Bachelor's degree with 0 years of experience required.
    • In lieu of a Bachelor’s Degree, a high school diploma/GED with 4+ years of experience in a regulated laboratory environment OR an Associate’s Degree with 2+ years of experience working in a regulated laboratory environment, also accepted 
    • Lab experience in Environmental Monitoring and Microbiology highly desired
    • BS degree in Biology or Microbiology is preferred
  • Technical and scientific knowledge working with microbiological laboratory techniques, testing, and quality principles (GMP/GLP) preferred.
  • Experience in the use of software tools for data entry and analysis (LIMS); technical writing skills preferred.
  • Strong organizational skills, the ability to prioritize work and manage multiple tasks independently. 
  • Excellent and effective verbal and written communication skills; Teamwork orientation. 
  • Ability to problem solve/troubleshoot and provide solutions with minimal supervision. 
  • Ability to proactively identify opportunities for improvements and provide suggestions for improvements.

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BioFire Diagnostics, LLC. is an Equal Opportunity/Affirmative Action Employer. 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 BioFire Diagnostics’ application process by contacting us via telephone at (385) 770-1132, by email at [email protected], or by dialing 711 for access to Telecommunications Relay Services (TRS).

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