BioReagents Formulator (A Shift)

2 Days ago • 2 Years +

Job Summary

Job Description

The BioReagents Formulator will perform tasks in compliance with company policy and the BioFire Diagnostics’ Quality System. Responsibilities include maintaining records, operating production equipment, and formulating reagents. The role involves maintaining a clean environment, assisting with in-process testing, and performing additional tasks as assigned. The position requires working under supervision and reporting to the Reagent Production Supervisor.

Must have:

Compliance with company policy and Quality System.
Maintaining records per regulatory requirements.
Operating production equipment for formulation.
Responsible for reagent formulations and sub-assemblies.
Maintaining a clean formulation lab environment.

Good to have:

Experience with pipetting/liquid handling.
Technical writing and reviewing skills.
Experience with detail-oriented work.
Knowledge of commonly used concepts like PCR.

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Job Details

Primary Duties:

Perform all work in compliance with company policy and within the guidelines of BioFire Diagnostics’ Quality System.
Maintains records in compliance with regulatory requirements, current Good Manufacturing Practices, and Standard Operating Procedures.
Relies on pre-established written guidelines to perform job functions.
Operates Production Equipment
Responsible for wet and freeze-dried reagent formulations, sub-assemblies, and finished goods.
Responsible for maintaining a clean environment of formulation labs and associated spaces.
May assist with in-process testing to assure batches or lots meet specifications.
Performs additional tasks as assigned by management.
Works under immediate supervision of the BFDX Formulation Team Lead and reports to the BFDX Reagent Production Supervisor.
Performs other duties as assigned.

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.

In lieu of degree: 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, 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.

Work 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.

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BioMérieux Inc. and its affiliates are Equal Opportunity/Affirmative Action Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information. Please be advised that the receipt of satisfactory responses to reference requests and the provision of satisfactory proof of an applicant’s identity and legal authorization to work in the United States are required of all new hires. Any misrepresentation, falsification, or material omission may result in the failure to receive an offer, the retraction of an offer, or if already hired, dismissal. If you are a qualified individual with a disability, you may request a reasonable accommodation in BioMérieux’s or its affiliates’ application process by contacting us via telephone at (385) 770-1132, by email at recruitment@biomerieux.com, or by dialing 711 for access to Telecommunications Relay Services (TRS).