QC Technologist II works in a cGMP environment performing quality control testing for commercial and diagnostics products. This individual will primarily conduct quality control testing, inspection, and data reporting on manufactured or repaired products. Responsibilities include conducting testing of reagents, instruments, completing validations, environmental swab testing, equipment calibrations, and working with other departments for data collections and validations for new product QC qualifications. This position will work in a laboratory setting and perform a variety of scientific techniques, including spectrophotometry, PCR, pipetting, etc.   

Primary Duties 

• Perform all work in compliance with company policy and within the guidelines of BioFire Diagnostics’ Quality System.
• Performs quality control testing on incoming reagents used in FilmArray and SpotFire systems.
• Maintains supply stocks and completes inventory counts.
• Provide support if needed in validations or other projects for various departments within the company.
• Responsible for learning new techniques or workflow as required for new product lines, equipment, and softwares.
• Responsible for Cal/PMs, equipment/instrument troubleshooting as needed, coordinating equipment/instrument repairs and installation of new fleet instrument systems.   
• Responsible for swab collection, set up, reporting, and monitoring for Environmental Swab testing program.
• Perform accurate and efficient QC data entry.
• Maintaining the QC area to ensure that it is clean and contamination-free including participation in cleaning and swabbing as assigned.
• Coordinates repeat testing.
• Works closely with IQC Supervisor, Manager, and colleagues to ensure consistent and timely turnaround for QC results.
• Responsible for data review, daily data reporting, product release, and generating Non Conformance Reports when appropriate. 
• Responsible for maintaining records as required by the Quality System.
• Performs other duties as assigned.
• Perform all work in compliance with company quality procedures and standards.

• Must work assigned shift and have ability to work flexible schedule.
• Must work mandatory overtime as assigned. 
• Must work full time hours as defined by the department. 
• Must have the ability to efficiently work independently without direct supervision  

Qualifications

• High School Diploma or GED. 
• Minimum 4 years previous experience in a laboratory setting (either academic or professional) is required in any of the following areas:
  • Quality Control testing or inspection
  • Engineering testing
  • Scientific laboratory testing
  • or Instrument Calibration and Maintenance

Preferred Education, Training and Experience   

• Associate’s degree or equivalent education in a life science, physical science, or related field 
• Experience in medical devices strongly preferred   
• Experience in instrument calibration and maintenance
• Final Quality Control testing preferred

• Acting with Honor and Being Open Consistently upholds and reflects the core ethical principles and values that bioMérieux promotes.
• Managing Work Processes
• Troubleshooting issues to identify and resolve problems efficiently
• Communicating Effectively
• Effective verbal communication skills
• Effectively deal with ambiguity requiring adaptability, critical thinking, and proactive communication to navigate situations with limited details
• Detail orientation to complete tasks without errors and produce high-quality work.
• Thriving in a fast-paced environment by managing tasks, multitasking, and adapting quickly to maintain productivity.
• Functional skills including critical thinking, adaptability, time management, communication, problem-solving and digital literacy.
• Build and maintain positive, productive interactions with colleagues
• Practicing time management to allocate tasks, balance priorities, and meet deadlines efficiently
• 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
• Mathematic competency
• Highly collaborative and team oriented
• Demonstrated proficiency with various pipettes is required for this position

Working Conditions and Physical Requirements

• Ability to remain in stationary position, either sitting or standing, for prolonged periods.
• Ability to wear PPE correctly most of the day.
• Ability to adjust or move objects up to 50 pounds in all directions.
• Must be able to perform duties wearing a Powered Air Purifying Respirator (PAPR).
• Must be able to perform repetitive tasks with hands for a moderate amount of time.
• Must be able to look at computer monitors for an extended amount of time with or without accommodation.