QC Technologist works in a cGMP environment performing quality control testing for commercial and diagnostics products. Responsibilities include conducting testing of reagents and IVD materials as well as personnel swabs. Responsibilities include working with 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.

QC Technologist is also responsible for gathering and filling out quality documents pertaining to quality control testing, generation of Non-Conformance Report (NCR) when necessary and Temporary Change Order (TCO) application.

This position will work in a laboratory setting and perform a variety of scientific techniques, including spectrophotometry, PCR, pipetting, etc.

Essential Job Duties and Responsibilities

1. Perform all work in compliance with company policy and within the guidelines of BioFire Diagnostics’ Quality System.
2. Performs quality control testing on incoming reagents used in Film Array.
3. Maintains supply stocks as well as coordinating instrument/equipment repairs as necessary.
4. Provide support if needed in other projects or validations from various departments within the company.
5. Responsible for learning new techniques or workflow as required for new product lines.
6. Responsible for swab set up and reporting for personnel Swab testing program.
7. Perform accurate and efficient QC data entry.
8. Maintaining the QC area to ensure that it is clean and contamination-free including participation in cleaning and swabbing as assigned.
9. Coordinates repeat testing.
10. Works closely with QC Supervisor and colleagues to ensure consistent and timely turnaround for QC results.
11. Responsible for maintaining records as required by the Quality System.
12. Performs other duties as assigned.

Training and Education

•  Associate degree or higher in a Life Science or related field.

 Experience

•  Technologist - Minimum 6 months previous experience in a laboratory setting (either academic or professional) is required.

 Knowledge, Skills and Abilities

• Mathematic competency
• Excellent attention to details
• Ability to accurately follow both written and verbal instruction
• Demonstrated proficiency with Microsoft Office Suite
• Effective communication skills, both written and verbal
• Highly collaborative and team oriented
• Demonstrated proficiency with various pipettes is required for this position.

Physical Requirements

• Must be able to perform duties wearing a Powered Air Purifying Respirator (PAPR).
• Must be able to lift <25lbs.

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