Risk Assessment Specialist

  • location: Bedford, MA
  • type: Permanent
  • salary: $50,000 - $55,000 per year
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job description

Risk Assessment Specialist

job summary:
Contract research and testing company with main laboratory located in Bedford MA is actively seeking (1) skilled Risk Assessment Specialist to start immediately. The position is in Toxicological Risk Assessment (TRA), which report to the Director of ToxSmart, the company's Consulting Group. This is a unique opportunity to play a key role in a dynamic and thriving group. The selected candidate will enjoy the enormous visibility and entrepreneurial freedom that comes with working in a tight and highly-energized team. Exposure to diverse therapeutic and medical device areas adds to the excitement of working in this dynamic business.

Candidate will be responsible for all aspects of TRA as per ISO 10993-17 and ICH M7 guidelines, which will include literature-based research and review, exposure modeling, complex data review, investigation of medical device manufacturing practice and usage, and the preparation of technical summaries and reports. Therefore, a background in toxicology, or other life science is likely required. The work is tied to the chemical characterization of a test article and the Extractable/Leachable (E/L) analysis performed as per ISO 10993-18, therefore, a background in chemistry would be a plus. Other responsibilities include providing technical and administrative support in a manner that is respectful of client deadlines. Successful candidate will be a good communicator, with proficient writing skills, and will be able to work autonomously at times, on self-contained projects. He or she will be expected to be organized, detail-oriented, and adept at prioritizing work.

The company's mission continues to focus on providing pre-clinical services, competitively priced, with on-time delivery for the Pharmaceutical, Medical Device and Biotech industries. Great location off route 95 with plenty of great shopping locations, restaurants and hiking/walking trails in historic Bedford MA.

location: Bedford, Massachusetts
job type: Permanent
salary: $50,000 - 55,000 per year
work hours: 8 to 4
education: Bachelors
  • Excellent technical, written, and communication skills
  • Strong organization and administrative skills
  • Strong problem-solving and analytical skills
  • Willingness to adapt to rapidly changing scientific and regulatory environments
  • Supporting sales and all business development processes
  • Proficient with databases and Microsoft applications
  • BS with experience in risk assessment or toxicology, or Masters degree in a life science required.
  • High energy and entrepreneurial
  • Enjoys working in a "roll-up your sleeves" environment
skills: Data Analysis, Analytical Chemistry, Biology, RMP (Risk Management Plan), ICH Regulations
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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