Quality Technician I - Reagents (D Schedule)

Position Summary:

The Quality Assurance (QA) department provides Quality support across various departments within BioFire. The department is organized into six distinct subunits, consisting of Calibration & Preventive Maintenance, Document Control, BioReagents Manufacturing, Instrument Manufacturing, Servicing, and Incoming Material QC.

This is a full-time, non-exempt (hourly) position on the BioReagents Manufacturing Quality Assurance (QA) team. This individual will primarily review quality records and inspect manufactured products. Timely, accurate work is expected. The work is fast-paced, and requires prioritization of daily tasks and attention to detail. Effective communication, written and verbal, is critical. This position regularly interacts and collaborates with other departments within BioFire. The work is performed in real-time following standard practices and in accordance with the Quality System.

Principle Job Duties and Responsibilities:

1. Perform all work in compliance with company policy and within the guidelines of BioFire Diagnostics’ Quality System.
2. As a Quality representative, candidate will be responsible for reviewing, assessing and monitoring process and product to ensure compliance to requirements.
3. May contribute to other Quality Assurance subunits that are outside of their primary Quality Assurance subunit, as assigned.
4. Determine product acceptance status after inspection.
5. Identify and escalate non-conformances observed during inspection.
6. Ensure good documentation practices during document review and inspection.
7. Release work in process to finished goods inventory. Report inconsistent or incorrect records to appropriate systems. Report errors to supervisor. Work with production teams to resolve erroneous records.
8. Inspect product to specification or process. Report non-conforming product to appropriate systems.  Report errors to supervisor. Work with production teams to resolve non-conformances where possible.
9. Physically quarantine non-conforming products and seek guidance on reporting the quarantined materials

Principal Decisions:

1. Determine product acceptance status after inspection, second-person verification (SPV), and UDI label grading.
2. Identify and escalate non-conformances observed during inspection and second-person verification.
3. Evaluate calibration and preventative maintenance forms for manufacturing equipment to determine accuracy, completeness, and to confirm equipment configuration meets specification and is acceptable for use.

Supplemental Data: 

This is an entry-level position within the company.  These employees are expected to understand the role of their team and activities of team members. Minimal domestic travel may be required for training purposes.

QUALIFICATIONS

 Training and Education: 

1. High school diploma or equivalent is required.
2. Associates degree in life science or engineering discipline preferred.
3. Knowledge of good manufacturing practices, ISO 9001, ISO 13485, and 21 CFR 820 preferred.

Experience: 

1. Work experience in a laboratory or life science manufacturing setting that has a formal quality system is preferred.
2. Minimum 2 years previous on-the-job experience requiring professional communication and interactions utilizing skills outlined below.
3. Any experience in Quality Assurance or Quality Control preferred.

Skills:  

1. Effective written and verbal communication skills
2. Proficiency in MS Office tools, including Outlook, Word, and Excel
3. General computer operation
4. Attention to detail is fundamental to this position
5. Ability to accurately follow written and verbal instructions
6. Organization as needed to maintain paperwork and task schedule

Physical Requirements: 

1. Perception of and ability to distinguish colors
2. Must be able to perform duties wearing a Powered Air Purifying Respirator (PAPR) as needed.
3. Must be able to perform duties in a clean room environment.  This requires the use of work attire provided and laundered by BioFire Diagnostics.
4. Must be able to lift at least 25 lbs and may be required to lift up to 50 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.