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Biology Scientist

3 months ago

Portland, Maine, United States Intellectt Inc Full time

Role: Research Scientist II

Location: South Portland, ME -04106

Duration: 06+ Months on W2

Responsibilities:

  • Participate in a Quality Management Systems Program, with the primary responsibility being the creation of high-quality written content to support regulatory submissions.
  • Daily interaction with technical documentation, documentation tasks to be performed with high throughput and attention to detail
  • Required to proofread, prepare, create, review, edit, and/or update Quality and Technical Documents including, but not limited to: SOPs, Design Control Documentation (Design and Development Plan, Customer Requirements, Product Requirements, Design Outputs, Design Verification Protocol and Reports), Technical Reports, Risk Management Documentation including FMEAs
  • Understands and is aware of the quality consequences which may occur from the improper product performance; has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing, and testing activities
  • May have supervisor duties for small teams and may direct staff in their day to day work and assist in problem solving.
  • Demonstrate technical proficiency in general laboratory techniques
  • Conduct experiments of a varied nature in support of on-market products
  • Works with multidisciplinary team including other scientists, researchers, and technicians.
  • Analyze experimental results and provide written reports and oral presentations to executives
  • Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company's policies and practices; build productive internal/external working relationships
  • Carries out duties in compliance with established business policies
  • Adapt rapidly to a changing industry and be able to adjust responsibilities, time and objectives accordingly
  • Perform other duties & projects as assigned

Basic Qualifications:

  • Bachelor's degree in Biology, Biochemistry or Chemistry, or related technical field
  • Minimum of 5+ years of progressively responsible positions in a research development environment with laboratory and technical writing experience working under design control and developing human in vitro diagnostic tests for commercialization in the U.S and OUS
  • Ability to work as part of a team with excellent communication skills
  • Problem-solving skills combined with analytical skills and attention to detail
  • Experience owning the end-to-end documentation creating process
  • Proficiency with Microsoft Office, specifically in Word, Excel, and PowerPoint
  • Must be able to productively generate quality documentation to meet program timelines