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IT Quality Analyst

Cambridge, MA

Job Type: Contract
Job Id : 307578
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Position Summary

Our client is one of the oldest independent biotech companies in the world, with a commitment to innovation, excellence, and continual improvement of quality of life for people around the globe. They are currently looking for an IT Quality Analyst to join their dedicated team.

Responsibilities of the IT Quality Analyst:

  • Oversee/approve system life cycle activities while following all regulations and protocol
  • Provide guidance and training to IT staff in regards to validation efforts to ensure compliance
  • Serve as an IT Quality SME on cross-functional teams
  • Advise on activities related to validation in regards to corporate SOPs and current regulations
  • Provide QA oversight for system related issues
  • Serve as SME on regulatory compliance, recommending corrective actions if necessary
Requirements of the IT Quality Analyst:
  • Bachelor's degree required; Master's degree preferred 
  • At least 7 years of experience in IT Quality/computerized system validation within a regulated environment (R&D preferred)
  • Thorough knowledge of GxP and ERES regulations and guidelines 
  • Detailed knowledge of the System Development Life Cycle (SDLC) and software QA in a regulated environment 
  • Thorough knowledge of IT Controls methodologies, including GAMPS and ITIL 
  • Experience with risk analysis and risk management practices and tools 
  • Excellent communication skills, both verbal and written 
  • Knowledge of general software, database concepts and data integrity 
  • Knowledge of infrastructure technology and platforms 
  • Ability to work both independently and with teams 
  • Ability to work in a fast-paced, deadline-driven environment
  • Demonstrated initiative and self-direction
Keywords: Quality, IT Quality, Analyst, IT Quality Analyst, SME, Subject Matter Expert, SOPs, Compliance, Regulatory Compliance, R&D, GxP, ERES, SDLC, GAMPS, ITIL, Risk Analysis, Risk Management, Communication, Data Integrity, Motivated

Job ID: 307578

About Eliassen Group:

Eliassen Group provides strategic talent solutions to drive our clients’ innovation and business results. Leveraging nearly 30 years of success, our expertise in IT staffing, Agile consulting, creative services, managed services, and life sciences enables us to partner with our clients to execute their business strategy and scale effectively. Headquartered in Reading, MA and with offices from coast to coast, Eliassen Group offers local community presence, deep networks, as well as national reach. For more information, visit http://www.eliassen.com.

Eliassen Group is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

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