QC Technologist III - Night Shift

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 a QC Technologist III!

***SIGN ON BONUS OFFERED***

• $500 on first paycheck
• $500 after 6 months of employment

Description of Responsibilities

Job Summary

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. In addition, 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, 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, Non Conformance Report (NCR) generation and Temporary Change Order (TCO) application. QC Technologist provides assistance in QC document revision. QC Technologist will be responsible for components and product releases both software-assisted and manual releases.

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

The schedule for this position will be Wednesday - Saturday 3:45 PM - 2:15 AM. 

Essential Job Duties and Responsibilities

1. Perform all work in compliance with company policy and within the guidelines of BioFire Diagnostics’ Quality System.
2. Perform quality control testing on incoming reagents used in Film Array.
3. Maintain supplies 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 workflows as required for new product lines.
6. Responsible for personnel swab set up and reporting.
7. Perform accurate and efficient QC data entry.
8. Maintain the QC area to ensure it is clean and contamination-free including participation in cleaning and swabbing as assigned.
9. Coordinate repeat testing activities.
10. Works closely with QC Supervisor and colleagues to ensure consistent and timely turnaround for QC results.
11. Maintain records as required by the Quality System.
12. Provide training for new employees.
13. Responsible for data review and component release.
14. Respond to inquiries and reviewing corrections.
15. Responsible for product release in Production Web and Component QC Tool.
16. Provides help or assistance in QC document revisions.
17. Generates Non Conformance Reports.
18. Performs troubleshooting as needed.
19. Performs other duties as assigned.

Qualifications

Training and Education

Associate Degree or higher in Life Science related field.  Bachelor’s degree is preferred.

Experience

5+ years of experience in a laboratory setting (either academic or professional) is required. Previous cGMP experience is strongly preferred.

Knowledge, Skills and Abilities

• Excellent attention to detail
• Ability to accurately follow both written and verbal instructions
• Demonstrated proficiency with Microsoft Office Suite
• Highly collaborative and team oriented
• Must be mathematically competent
• Effective communication skills, both written and verbal
• Demonstrated proper pipetting technique

Physical Requirements

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