16 days old
2017-11-022017-11-30

Validation/Quality Analyst in Cambridge

Cambridge, MA 02142
  • Job Code
    585701
  • Payrate
    $50 To $50

Summary of Key Responsibilities:


-Approve system life cycle deliverables (SDLC) and activities to ensure that procedures and methodologies are followed and that appropriate and complete documentation is captured and reported to support SDLC activities for assigned IT systems, including associated change requests.


-Represent IT Quality on all assigned IT projects in support of SDLC activities.


-Consult on the authoring and conformance of SDLC deliverables and activities in regards to corporate SOPs, policies and current regulations.


-Provide guidance, training, and support to IT personnel in their SDLC efforts, to ensure compliance.


-Provide quality assurance oversight for system related issues


-Act as a high-level technical resource to IT quality and customer base for interpretation of policy, review and approval of technical documents, and high level decision making.


-Employ risk-based methodology, where feasible and achievable.


Qualifications:


-Knowledge of IT Controls methodologies, including GAMP5 and ITIL


-Well-versed in GxP guidance, including 21 CFR Part 11, Annex 11 and Data Integrity


-Experience with system validation across GxP landscape, specifically R&D applications


-Excellent communication skills, both verbal and written as well as capable of presenting the right level of information to senior management


-Knowledge of the IT system development life cycle and software quality assurance in a regulated environment


-Knowledge of general software and database concepts


-Ability to work both independently and with teams at various levels in the organization


-Ability to work in a very dynamic environment with a clear sense of urgency.


-Exercises considerable independence in determining objectives and


approaches to assignments


-Excellent organizational skills and attention to detail and accuracy


-Life Sciences biotech / pharmaceutical experience


-Experience in HP ALM ideal.


-Experience supporting health authority inspections a plus.


-7+ or more years working in an IT SQA or Quality role. Must have hands-on IT experience and in-depth knowledge of FDA and International Regulations.


Education:


-BA/BS required in Life Sciences or IT related discipline

Categories

  • Information Technology

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Validation/Quality Analyst in Cambridge

Randstad Technologies
Cambridge, MA 02142

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Validation/Quality Analyst in Cambridge

Randstad Technologies
Cambridge, MA
US

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