QC Technologist II

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.
Supplemental Data
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
Knowledge, Skills, and Abilities
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.

Skills
Quality Control, Data Entry