Research Associate I/II - job 1 of 2

Description

Position Summary:

The Regulatory Affairs and Clinical Affairs departments are responsible for performance assessment and validation of molecular in vitro diagnostic products for global regulatory registrations.

The Research Associate I/II is a technical hourly position with laboratory responsibilities. The RA I/II 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 communicate and coordinate with peers and supervisor(s) effectively and respectfully.

The RA I/II position requires basic laboratory technical and organizational skills, attention to detail, critical thinking, troubleshooting and problem-solving, and a dedication to the mission and goals of the department and BioFire. A Research Associate I may receive general or detailed instruction and supervision on routine work, and detailed instruction and supervision on new procedures and assignments.

Responsibilities:

• Perform all work in compliance with company policy and within the guidelines of BioFire Diagnostics’ Quality System.
• Follow policies and procedures and conduct oneself professionally and in accordance with the BioFire Diagnostics Employment Handbook.
• 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.
• Use and maintain laboratory equipment, supplies/inventory, and workspaces according to operational, quality control and safety requirements, protocols, SOPs, and WIDs.
• Perform routine calculations and laboratory techniques, to include solution formulation, dilution, microbial culture and enumeration, nucleic acid extraction, real-time and/or digital PCR, as well as basic graphing and statistical analyses.
• Work in a Biosafety Level 2/2(+) environment with potentially pathogenic microbes, patient samples, and body fluids using sterile technique for contamination and infection control.
• May participate in maintenance of laboratory databases (e.g. for tracking of reagents, organism strains, samples, specimens, etc.).
• Act as a good lab citizen and team-member. Coordinate and collaborate with supervisors and peers within and across teams and functional groups for routine lab activities, cleaning, equipment use, specific assigned tasks and projects, and sharing of knowledge, skills, and ideas.
• Participate and contribute to protocol and process development, optimization, revision, and/or execution as well as risk or hazard identification and mitigation, commensurate with knowledge and experience.
• Train others on laboratory and departmental practices and procedures; commensurate with knowledge and experience.
• Develop knowledge and skill in time and task management, experimental design, and execution, as well as data compilation, analysis, and presentation (written and/or oral) to supervisors and peers.
• Gain and maintain a working knowledge of current and evolving microbiology and molecular biology principles.
• Attend and participate in all assigned meetings, including company and group meetings.
• Attend and participate in learning and training opportunities.
• Be curious, communicative, and committed to making ‘Cool Stuff’.

Training and Education:

The position requires a Bachelor’s degree in a scientific discipline or a minimum of two years of undergraduate education in a scientific discipline with demonstrated laboratory experience and working knowledge of basic chemistry, microbiology and/or molecular biology principles.

Experience:

RA I
No experience required. some lab experience is preferred.
RA II
2 or more years of relevant lab experience.

Skills and Qualifications:

Must demonstrate skill in basic laboratory technician practices (pipetting, biological and chemical material handling, sterile technique and contamination control, basic concentration and statistical calculations, and accurate record-keeping).

Basic competency 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.