Quality Analyst with GXP experience. in Cambridge, MA at Eliassen Group

Date Posted: 9/12/2019

Job Snapshot

  • Employee Type:
  • Location:
    Cambridge, MA
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:

Job Description

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 a IT Quality Analyst to join their dedicated team.

Due to client requirement, applicants must be willing and able to work on a w2 basis. For our w2 consultants, we offer a great benefits package that includes Medical, Dental, and Vision benefits, 401k with company matching, and life insurance.

Responsibilities of the IT Quality Analyst:

  • Support the implementation of GxP computerized systems and infrastructure, ensuring alignment with all relevant regulatory requirements
  • Support data integrity implementation and remediation of GxP systems and infrastructure
  • Review technical and strategy documents: standards, requirements, design, testing, processes, etc.
  • Assist with technical writing and review of CAPA and deviations
  • Provide training support to IT resources to ensure compliance

Requirements of the IT Quality Analyst:

  • At least 3 years of experience in CSV or quality position support computerized systems
  • Experience remediating GxP systems using risk-based methodologies
  • In-depth understanding of relevant regulations governing computer systems and controls
  • Ability to interpret regulatory guidance and enterprise policies into life cycle documentation
  • Ability to complete tasks with minimal oversight
  • Background in life sciences and/or pharma/biotech industries

Keywords: IT Quality Analyst, GxP, SDLC, CAPA, Regulatory Compliance, Biotechnology, Pharmaceutical

Job ID: 321542

About Eliassen Group:

Eliassen Group provides strategic talent solutions to drive our clients’ innovation and business results. Leveraging over 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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