SDLC Multiple Tasks GXP GAMP Analyst (Jobs in Cambridge, MA)   Requirement id 70718 Job title Analyst Job location in Cambridge, MA Skills required SDLC, IT Quality Process, System Requirements, Multiple Tasks GXP GAMP Open Date 14-Jun-2018 Close Date Job type Contract Duration 6 Months Compensation DOE Status requirement --- Job interview type Phone Screen and Face to Face interview    Email Recruiter: coolsoft Job Description Analyst: SDLC, IT Quality Process, System Requirements, Multiple Tasks GXP GAMP End date : 12/24/2018 (fixed) Client Info : Biotechnology, Pharmaceuticals and Medicine Description: Responsibilities Our client in Cambridge, Massachusetts is seeking an IT Quality Analyst - Compliance **Responsible for: ** • Approve system life cycle deliverables (SDLC} and activities to ensure that regulations, protocols, procedures, and methodologies are followed, and 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. This job requires the IT Quality Analyst to attend department and user meetings, system assessment meetings, trainings, and other essential tasks. The IT Quality Analyst must maintain a professional manner in representing the company and in working with its agents and associates. The individual should demonstrate initiative and self-direction while also knowing when to seek assistance. This person must also be able to routinely schedule and complete multiple tasks and be timeline driven. Professional competences **Requirements ** • Bachelors/Masters Degree • 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   Call 502-379-4456 Ext 100 for more details. Please provide Requirement id: 70718 while calling.   Other jobs in MA: Boston (103), Burlington (1), Cambridge (1), Canton (3), Chelsea (9), Franklin (1), Lexington (2), Malden (10), Marlborough (2), Maynard (2), Newton (1), Quincy (6), Sharon (1), Waltham (1), Welesley (1), Wellesley (6), Westborough (1), Westbourough (1), SDLC job openings in Cambridge, MA Jobs List IT Architect-Medical - 43734 Create date: 20-Feb-2019 Candidate must be your W2 Employee. Job Description : It has an opportunity for an IT Architect role in the Cambridge, MA area. This is a 6-18 month contract position Location: Cambridge, MA Duration: 6-18 month contract Position Description: Our client is a Large Biotech Company lo.... (This job is for - SDLC TOGAF SOA Jobs in MA Cambridge Architect - (in Cambridge, MA)) Business Analyst - 40985 Create date: 03-Dec-2018 Candidate must be our own W2 Employee Job Description : Business Analyst The details for the role are below. 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