W-2 Jobs Portal

  • W-2 Open Positions Need to be Filled Immediately. Consultant must be on our company payroll, Corp-to-Corp (C2C) is not allowed.
Candidates encouraged to apply directly using this portal. We do not accept resumes from other company/ third-party recruiters

Job Overview

  • Job ID:

    J38536

  • Specialized Area:

    Quality Analyst

  • Job Title:

    IT Quality Analyst

  • Location:

    Cambridge,MA

  • Duration:

    12 Months

  • Domain Exposure:

    Manufacturing, Education, IT/Software

  • Work Authorization:

    US Citizen, Green Card, OPT-EAD, CPT, H-1B,
    H4-EAD, L2-EAD, GC-EAD

  • Client:

    To Be Discussed Later

  • Employment Type:

    W-2 (Consultant must be on our company payroll. C2C is not allowed)

  • Bench Recruiter:

    Vivian Ryan




Job Description

Job Description

Job Role: IT Quality Analyst

Responsibilities:
  • Approve system life cycle deliverables (SDLC} and activities to ensure that regulations, protocols, procedures, and methodologies are followed
  • Ensure that appropriate and complete documentation is captured and reported to support validation activities
  • Represent IT Quality on cross-functional teams with IT R & D in support of SDLC activities
  • Consult on the authoring and conformance of validation-related deliverables and activities in regards to corporate SOPs and current regulations
  • Provide guidance, training and support to IT personnel in their validation efforts, to ensure compliance
  • Provide quality assurance oversight for system related issues (Test incidents, issues, etc.)
  • Advise technical personnel and project teams on regulatory compliance and interpretation and recommend appropriate corrective actions where needed
  • Attend department and user meetings, system assessment meetings, trainings, and other essential tasks
  • Maintain a professional manner in representing the company and in working with its agents and associates
  • Demonstrate initiative and self-direction while also knowing when to seek assistance

Requirements:
  • Bachelor's or Master's Degree
  • Ability to routinely schedule and complete multiple tasks and be timeline driven
  • At least 7 years IT Quality / Validation experience in computerized system validation within a regulated environment preferably R & D application
  • Thorough knowledge of GxP and ERES (21CFR Part 11 and Annex 11) regulations and guidelines
  • Detailed knowledge of the IT system development life cycle and software quality assurance 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
  • The ability to work both independently and with teams

Apply Now
Equal Opportunity Employer

QUANTUM TECHNOLOGIES LLC is an equal opportunity employer inclusive of female, minority, disability and veterans, (M/F/D/V). Hiring, promotion, transfer, compensation, benefits, discipline, termination and all other employment decisions are made without regard to race, color, religion, sex, sexual orientation, gender identity, age, disability, national origin, citizenship/immigration status, veteran status or any other protected status. QUANTUM TECHNOLOGIES LLC will not make any posting or employment decision that does not comply with applicable laws relating to labor and employment, equal opportunity, employment eligibility requirements or related matters. Nor will QUANTUM TECHNOLOGIES LLC require in a posting or otherwise U.S. citizenship or lawful permanent residency in the U.S. as a condition of employment except as necessary to comply with law, regulation, executive order, or federal, state, or local government contract