BioReagents Formulator (D Shift)

Primary Duties:

Schedule: Thursday thru Saturday and every other Wednesday from 6:00pm to 6:00am

1. Perform all work in compliance with company policy and within the guidelines of BioFire Diagnostics’ Quality System.

2. Maintains records in compliance with regulatory requirements, current Good Manufacturing Practices, and Standard Operating Procedures.

3. Relies on pre-established written guidelines to perform job functions.

4. Operates Production Equipment

5. Responsible for wet and freeze-dried reagent formulations, sub-assemblies, and finished goods.

6. Responsible for maintaining a clean environment of formulation labs and associated spaces.

7. May assist with in-process testing to assure batches or lots meet specifications.

8. Performs additional tasks as assigned by management.

9. Works under immediate supervision of the BFDX Formulation Team Lead and reports to the BFDX Reagent Production Supervisor.

10. Performs other duties as assigned

Training and Education:

Required completed two years, or equivalent, of college coursework and lab experience or 2+ years of work lab experience in an FDA/ISO regulated industry in lieu of education.

Preferred- Bachelor’s degree/4-year program with an emphasis on a biological science. 1+ years scientific/laboratory experience. 1+ years cGMP.

Experience:

Preferred - Experience pipetting/liquid handling, technical writing/reviewing, detail-oriented work. Software (Word, Excel, Web browser).

Knowledge, Skills, Abilities:

Proficient in math, specifically unit conversions. Good oral/written communication, pipetting/liquid handling of multiple volumes. Maintain attention to detail for extended periods of time. Execute repetitive tasks and maintain high level of consistency over time. Has knowledge of commonly used concepts, practices, and procedures including PCR, RT-PCR real-time PCR, and use of fluorescence based nucleic acid detection techniques.

Working Conditions:

Ability to remain in stationary position, often standing, for prolonged periods.

Ability to wear PPE correctly most of the day.

Ability to adjust or move objects up to 50 pounds in all directions.

Able to safely lift and maneuver up to 50 lbs. Standing and/or sitting 2+ hours at time. Able to perform duties while wearing a Powered Air Purifying Respirator (PAPR).