Senior Quality Technician - Reagents (C Schedule)

Description

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:

• Perform all work in compliance with company policy and within the guidelines of its Quality System.
• Responsible for reviewing, assessing and monitoring process and product to ensure compliance to requirements.
• May contribute to other Quality Assurance subunits that are outside of their primary Quality Assurance subunit, as assigned.
• Proficiently:
  • Inspect product (including labels) to specifications and established procedures. Determine product acceptance status after inspection.
  • Identify and escalate non-conformances observed during inspection. Work with production teams to resolve non-conformances where possible.
  • Ensure good documentation practices during quality document and quality record review. Report inconsistent or incorrect records to appropriate systems. Work with production teams to resolve erroneous records.
  • Physically release work in process for finished goods processing
  • File and archive quality records according to established processes.
  • Prioritize product release to meet department goals
  • Identify and report floor failures observed during sweeps of manufacturing areas.
  • Review and approve Device History Records.
  • Receive and hold finished goods inventory until release is authorized
  • Release finished goods to stock inventory
  • Coordinate molded part validation inventory
  • Confirm manufacturing equipment meets requirements for release to Manufacturing Engineering for validation.
  • Confirm manufacturing equipment meets specifications for release to Reagent Manufacturing for use.
  • Control (physically and electronically) material suspected to be non-conforming
    
    

QUALIFICATIONS

 Training and Education: 

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

Experience: 

1. Minimum 1-year previous on-the-job experience requiring professional communication and interactions utilizing skills outlined below.
2. Minimum additional 1-year experience in a Quality Assurance, Quality Control, laboratory or life science or other manufacturing setting that has a formal quality system. Education/certification in Quality Management Systems may be used in lieu of this experience.

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 skills as needed to maintain paperwork and task schedule.
7. Proficiency in internet navigation
8. Basic math proficiency

Physical Requirements: 

1. Must be able to lift at least 25 lbs and may be required to lift up to 50 lbs.
2. 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 travel (if necessary).
3. Must be willing to submit to a color-vision test, though result of the test will not determine employment eligibility
4. Must be able to perform duties wearing a Powered Air Purifying Respirator (PAPR) as needed.
5. Must be able to perform duties in a clean room environment. This requires the use of work attire provided and laundered by the company.
6. Must be able to push, pull, bend, and/or lift at least 25 lbs, and may be required to lift up to 50 lbs., for extended periods of time on a daily basis.