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QA Analyst - GxP Systems in Durham, NC at Eliassen Group

Date Posted: 1/23/2019

Job Snapshot

  • Employee Type:
    Contractor
  • Location:
    Durham, NC
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
    1/23/2019

Job Description

Eliassen Group is seeking an QA Analyst with experience supporting applications in a pharmaceutical setting, employing GxP procedures, and ensuring compliance with federal regulations. This is a long term contracting position located in the Raleigh/Durham area.

Due to client requirement, all 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 QA Analyst - GxP Systems:

  • Support quality assurance of R&D system validation implementations
  • Maintain SDLC deliverables and systems that are compliant with both regulatory requirements and enterprise standards
  • Review and approve SDLC validation documentation
  • Assess change control documentation for compliance, validation, and GxP impact
  • Participate in project meetings and offer input on QA matters
  • Review and approve SOPs

Requirements of the QA Analyst - GxP Systems:

  • At least 7 years of experience in computerized system validation in a regulated environment
  • In-depth knowledge of IT system development life cycle and software quality assurance in a regulated environment
  • Experience performing risk assessments and validating SaaS solutions
  • Comprehensive knowledge of data integrity requirements
  • Strong knowledge of GxP and ERES regulations and guidelines
  • Experience with MS Office Suite, Outlook, and similar business software programs
  • Ability to work independently and in a team environment across all levels of the organization
  • Solid organizational skills and strong attention to detail and accuracy 
  • Experience with HP ALM preferred

Keywords: QA Analyst, GxP Systems, System Development Life Cycle, Software Quality Assurance, Risk Assessment, ERES, HP ALM, SOPs, Biotechnology, Pharmaceutical

Job ID: 314624

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.

Don’t miss out on our referral program! If we hire a candidate that you refer us to then you can be eligible for a $1,000 referral check!