BioReagents Formulator I (D Shift)

Description

Responsible for manufacturing products efficiently, accurately, safely and on time. Operates manufacturing equipment and in-process instrumentation to manufacture regulated products in accordance to QSRs, company policy and safety regulations. Works on assignments that are routine in nature where ability to recognize deviation from accepted practice is required. Position requires attention to detail and fine motor dexterity. Relies on instructions and pre-established guidelines to perform the functions of the job and requires direct supervision or oversight by a senior employee. Works under immediate supervision of the BFDX Formulation Team Lead and reports to the BFDX Reagent Production Supervisor.

Primary Duties:

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.

Education and Training:

Minimum Level of Education Required High School Diploma, GED or equivalent

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

Experience:

1. Work experience in an FDA/ISO regulated industry 1 plus years of applicable experience

Knowledge, Skills, Abilities:

Effective verbal communication skills

Organizing work and resources efficiently to ensure smooth operations

Detail orientation to complete tasks without errors and produce high-quality work.

pipetting/liquid handling of multiple volumes.

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.