R&D/GXP Quality Analyst contract, Cambridge, MA in Cambridge, MA at Eliassen Group

Date Posted: 7/28/2020

Job Snapshot

  • Employee Type:
    Contractor
  • Location:
    Cambridge, MA
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
    7/28/2020

Job Description

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.

Our biopharma client needs an R&D IT Quality Analyst to join their growing team. This is NOT a QA tester role.  

We are looking for somebody with a background in Computer Systems Validation and GXP.  

Responsibilities of the Quality Analyst:
  • Guide, train, and support IT teams in validation tasks to ensure compliance
  • Approve validation related deliverables and activities to ensure alignment with enterprise SOPs and current regulations
  • Advise technical personnel and project teams on regulatory compliance and appropriate corrective actions
Requirements of the Quality Analyst:
  • Bachelor's degree and at least 7 years of IT quality/validation experience in computerized system validation within a regulated environment
  • Comprehensive understanding of GxP and ERES (21 CFR Part 11 and Annex 1) regulations and guidelines
  • In-depth knowledge of IT system development life cycle 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 collaboratively
Keywords: Quality Analyst, R&D, GxP, Computer Systems Validation, SDLC, Biopharma

Job ID: 338634

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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