Bioreagents Formulator (D Shift)

Job Information

Business Title

BioReagents Formulator

Department

Reagent Manufacturing

Cost Center

2802140_Mfg Reagents_FAFORM

Title of Direct Supervisor

Reagent Production Supervisor

Description of Responsibilities

Position Summary

This is a full-time non-exempt position.

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.

Responsible for manufacturing and formulation of some BioReagents products and sub-assemblies including FilmArray. Weighs, measures, and checks raw materials to assure that manufactured batches, lots, buffers and sub-assemblies contain the proper reagents and qualities. Assists in complex functional testing and troubleshooting product, process material or formulation processes. Applicant must be mathematically competent, detail orientated, and able to follow written directions well. Familiar with a variety of the field’s concepts, practices, and procedures. A wide degree of organization and attention to detail is expected. Works with minimal instruction on routine work and Lead oversight/ instruction on new assignments.

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.

Supplemental Data

None.

Qualifications

Training and Education

Minimum -Completed two years, or equivalent, of college coursework or 2+ years of work 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.

Check the highest-level education required (must be job-related).  Identify the discipline, where applicable:

Bachelor’s Degree

Will work experience be accepted in lieu of a degree?      Yes  

If yes, number of years of experience accepted in lieu of degree and type: two years, or equivalent, of college coursework or 2+ years of work experience in an FDA/ISO regulated industry in lieu of education

Experience

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

Knowledge, Skills, and 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 and Physical Requirements

Check if applicable

 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.

 Domestic travel required    ____ % of time

 International travel required   ____ % of time

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).

Supervisory Responsibilities

     N/A

Management Scope

Check appropriate decision-making authority below:

Decisions with long-term impact

 With supervisory review/approval required

Decisions with short-term impact

 With supervisory review/approval required