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Research Associate III

Cette offre d'emploi n'est plus active.

Localisation: Salt Lake City, UT, États-Unis
Type de Contrat: Unfixed Term
Fonction: Regulatory Affairs

Description

The Research Associate III is a salaried position with laboratory responsibilities. The RA III works to meet deadlines in a dynamic environment and has the temperament to operate proactively and collaboratively in a team in support of FDA and other regulatory submissions. Tasks will focus on molecular and microbiological experiments and procedures (e.g. nucleic acid extraction, serial dilution, PCR, bacterial and fungal culture, etc.) with associated collection, analysis, verification and recording of data in accordance with established protocols and work instruction documents, regulations, safety requirements, and the quality system. Work is primarily collaborative and requires the ability to effectively and respectfully communicate and coordinate with peers and supervisor(s).

The position requires proficiency in laboratory technical and organizational skills, attention to detail, critical thinking, troubleshooting and problem-solving, data analysis, sequence analysis and a dedication to the mission and goals of the department and BioFire. Microbiology training and familiarity with Biosafety Level 2 practices are a plus. Compilation of data into clear reports or presentations is expected. A Research Associate III is expected to self-direct in work and assignments with minimal supervision. A Research Associate III may function as project lead under the supervision of a scientist.

Essential Job Duties and Responsibilities 

1. Perform all work in compliance with company policy and within the guidelines of BioFire Diagnostics’ Quality System.
2. Follow policies and procedures and conduct oneself professionally and in accordance with the BioFire Diagnostics Employment Handbook.
3. Ensure data integrity and accurate record-keeping by collecting, recording (laboratory notebooks and study worksheets), analyzing, and verifying data in compliance with SOPs, WIDs, and Study Protocols.
4. Coordinate use and maintenance of laboratory equipment, supplies/inventory, and workspaces according to operational, quality control, and safety requirements, protocols, SOPs, and WIDs.
5. Train others on laboratory and departmental practices and procedures. May assist leadership in coordinating the work of fellow team members.
6. May participate in scientific conferences.
7. Perform routine or complex calculations and laboratory techniques, to include solution formulation, dilution, microbial culture and enumeration, nucleic acid extraction, real-time and/or digital PCR and sequencing, as well as graphing data, statistical analyses and primer/sequence/assay evaluation.
8. Work in PCR labs and a Biosafety Level 2/2(+) environment with potentially pathogenic microbes, patient samples, and body fluids using sterile technique for contamination and infection control.
9. Maintains laboratory databases (e.g. for tracking of reagents, organism strains, samples, specimens, etc.)
10. Act as an exemplary lab citizen and team-member. Proactively coordinate, collaborate, and communicate with supervisors and peers within and across teams and functional groups for lab activities, cleaning, equipment use, specific assigned tasks and projects, and sharing of knowledge, skills, and ideas.
11. Lead investigations and complex experiments, as well as protocol and process development, optimization, revision, and execution. Play an active role in anticipating, identifying, and mitigating risks or hazards in processes, experiments and projects.
12. Use data and critical thinking to evaluate successful performance and/or deficiencies in products and experiments. Includes identification of patterns and trends, and critical review of results. Propose strategies and solutions for technical and operational issues and when deficiencies are identified.
13. Exercise good judgement and prioritization in time and task management, experimental design and execution, and presentation of results and outcomes (written and/or oral) to supervisors and peers. Be accountable for task completion and follow-through to maintain project goals and timelines. Balance competing tasks from multiple projects.
14. Build upon current knowledge of tools and techniques in infectious disease diagnostics, microbiology and molecular biology principles, and regulatory processes.
15. Attend and actively contribute to all assigned meetings, including company and group meetings.
16. Attend and participate in learning and training opportunities.
17. Be curious, communicative, and committed to making ‘Cool Stuff’.

Qualifications

Training and Education

Requires a Bachelor’s degree. A Master’s degree in a scientific discipline is a plus.

Experience

Master’s degree in biology, microbiology or equivalent and two years of relevant experience or Bachelor’s degree with at least five years of experience, preferably in a clinical or industrial setting.

Knowledge, Skills and Abilities

  1. Must be proficient in basic chemistry, microbiology and molecular biology lab practices. Knowledge or experience in infectious disease and clinical laboratory diagnostics preferred.
  2. Mastery of common laboratory procedures.
  3. Ability to independently manage projects and employees and report areas of risk as they arise.
  4. Experimental design and data analysis.
  5. Scientific/Technical writing and oral presentations.
  6. Preferred to have experience with product validation, regulatory testing, knowledge of clinical laboratory testing and/or proficiency with data management and analysis applications.
  7. Proficiency with Microsoft Office (Outlook, Excel, Powerpoint, and Word).                               
Physical Requirements

Must be able to safely lift and maneuver 40lbs. Must have sufficient manual and visual dexterity for standard laboratory practices (e.g. pipetting, microcentrifuge tube capping/uncapping, syringe manipulation, etc.; reasonable accommodations are applicable). Able to wear required personal protective equipment (PPE) and work at a Biosafety Cabinet in a Biosafety Level 2/2+ laboratory environment. Must maintain regular and consistent attendance
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