- 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
- 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
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Biology Scientist - South Portland, United States - Intellectt Inc
Description
Role: Research Scientist II
Location: South Portland, ME -04106
Duration: 06+ Months on W2
Responsibilities:
Basic Qualifications:
