Description At BioFire Diagnostics, LLC. we make the world a healthier place by providing molecular solutions that lessen the time to medical results and empower healthcare professionals to make better diagnostic decisions.We are proud to be part of the bioMérieux family and the 5,000+ team members across 12 sites and subsidiaries in North America committed to our mission to help save lives around the globe through the power of diagnostics.Come be a part of our team and our mission as an Instrument QC Technologist I or II!
IQC Technologist I 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, and equipment calibrations. Responsibilities include working with the Manufacturing, Technology Transfer and other departments for data collections and validations for new product QC qualifications, organization of quality controlled materials used for QC testing, and learning new techniques or workflow as required by new product lines. Responsible for gathering and filling out quality documents pertaining to quality control testing and the generation of Non-Conformance Report (NCR) when necessary.
This position will work in a laboratory setting and perform a variety of scientific techniques, including spectrophotometry, PCR, pipetting, etc. This position will also include visual QC inspections that require knowledge on product function.
The schedule for this position will be Monday - Friday, with a flexible start time of 7-9AM. Essential Job Duties and Responsibilities
Training and Education
- Perform all work in compliance with company policy and within the guidelines of BioFire Diagnostics’ Quality System.
- Responsible for performing quality control testing on incoming reagents used in Film Array.
- Responsible for maintaining supplies and inventory counts.
- Responsible for coordinating instrument/equipment repairs as necessary.
- Provide support if needed in other projects or validations from various departments within the company.
- Responsible for learning new techniques or workflows as required for new product lines.
- Responsible for all instrument CAL/PMs, pipette calibrations, Artel system calibration, UV hood bulbs, etc.
- Responsible for all Film Array Contamination monitoring, collection, setup and reporting.
- Responsible for all other swab set up and reporting.
- Responsible for QC data entry.
- Responsible for maintaining the QC area clean and contamination-free.
- Responsible for coordinating repeat testing.
- Works closely with QC Manager, Instrument Production leads, Service Center leads, and Reagent QC to ensure consistent and timely turnaround for QC results.
- Responsible for maintaining records as required by the Quality System.
- Responsible for data review, reporting, and component release.
- Responsible for responding to inquiries and reviewing corrections.
- Responsible for product release in Production Web.
- Generates Non Conformance Reports.
- Reports daily metrics to management.
- Performs troubleshooting as needed.
- Performs other duties as assigned.
Associate Degree or higher in a Life Science or related field.
Technologist I - Minimum 6 months previous experience in a laboratory setting (either academic or professional) is required.Technologist II - Minimum of 2 years of experience in a laboratory setting or related area. Experience in cGMP environment is strongly preferred.Knowledge, Skills and Abilities
- Ability to accurately follow both written and verbal instructions
- Demonstrated proficiency with Microsoft Office Suite (Outlook, Word, and Excel)
- Highly collaborative and team oriented
- Highly organized and motivated
- Effective communication skills, both written and verbal
- Very high attention to detail
- Demonstrated proper pipetting technique
- Must be able to perform duties wearing a Powered Air Purifying Respirator (PAPR).
- Must be able to lift at least 25 lbs.
- Must be able to sit or stand for moderate amounts of time and look at computer monitors for an extended amount of time with or without accommodation.
- Must be able to perform repetitive tasks with hands for a moderate amount of time.