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 Apply    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. Here are the details: Position: Business Analyst Location: Cambridge, MA Duration: 1+ year The key activities for this position include: SDLC Business Analyst Jobs in MA Cambridge Analyst - (in Cambridge, MA)) Quality Engineer - 40154 Create date: 05-Nov-2018 Candidate must be our own W2 Employee Job Description : Position: Software Device Quality Engineer Position Description: High-Level Description: Software Device Quality Engineer Responsible for the quality oversight of design control and risk management for software as Me.... (This job is for - SDLC Jobs in MA Cambridge Engineer - (in Cambridge, MA)) Sr BA R And D IT Create date: 14-Aug-2018 Candidate must be our W2 Employee Job Description : The key activities for this position include: Co-Lead requirements elicitation sessions Develop process knowledge to translate to business and technical requirements Documentation of business processes and use cases Author of SDLC.... (This job is for - SDLCBiotech Jobs in MA Cambridge Consultant - (in Cambridge, MA)) Sr. Project Manager-LHS - 35356 Create date: 05-Jun-2018 Job Description : Responsibilities: Managing the timelines, budgets and resource scheduling needed to deliver new or enhanced systems and capabilities Preparing weekly status reports and identifying and managing any risks, issues and dependencies. Managing the budget and end-to-end project plan across mul.... (This job is for - SDLC PMO Jobs in MA Cambridge Manager - (in Cambridge, MA))    SDLC job openings in other states Jobs List PR687571-R131139 Applications Development Analyst -SP Create date: 18-Feb-2025 Bid URL: https://service.ariba.com/Supplier.aw/ad/collabReqDetail?requestDocId=30000000000000001371935347&anp=Ariba&community=3 Note: Online Submission Submission Deadline: 2/27/2025 5pm Start Date: 3/12/2025 End Date: 6/30/2025 Client: Florida Department of Transportation Description: .... (This job is for - SDLC SME Jobs in FL Tallahassee Analyst - (in Tallahassee, FL)) Software Test Analyst 5 - 139626 Create date: 03-Feb-2025 No of Submissions: 1 Start Date :3/3/2025 End Date :9/30/2025 Submission Deadline :2/10 at 10 am EST. Client Info: DHHS Note: * Remote or On-site: Candidates MUST be local at time of submission. Hiring manager is not currently interested in candidates who will need to.... (This job is for - SDLC Jobs in MI Lansing Analyst - (in Lansing, MI)) Business Analyst/Consultant IV - 139110 Create date: 27-Jan-2025 No of Submissions: 2 Start Date : 2/24/2025 End Date : 06/30/2025 Submission Deadline :1/31/25 at 4:00 PM CST. Client Info: DOC Note: * Interview Process: Teams interviews * Duration: June 30, 2025, with possibility of extension. * Remote or onsite? Candidate MUST.... (This job is for - EHR SDLC Jobs in WI Madison Analyst - (in Madison, WI)) Service Delivery Expert - 63274 Create date: 15-Oct-2024 No of Submissions : 2 Start date : 11/04/2024 End Date : 11/30/2026 Submission deadline : 10/18/2024 Client Info : NeDHHS Note : * Candidates can work remotely. Description : Service Delivery Expert DHHS Information System and Technology (IS&T) i.... (This job is for - SDLC Business Analyst Jobs in NE Lincoln Consultant - (in Lincoln, NE)) VDH Business Analyst 3 (748056) Create date: 03-Oct-2024 No of Submissions : 2 Start date : 11/04/2024 End Date : 06/30/2025 Submission deadline : 10/8/2024 Client Info : VDH Note: * Agency Interview Type : Both Web Cam and In Person Interview * Hybrid Description : *Local Richmond, VA candidates required .... (This job is for - SDLC Jobs in VA Richmond Analyst - (in Richmond, VA))    SDLC job openings in MA Jobs List Quality Assurance Test Manager - Lead - 58149 Create date: 10-May-2021 Description: The Quality Assurance Test Manager - Lead provides technical expertise in test automation to assist the software development team in improving development velocity with defect free code. This engineer must be able to perform test execution, defect management, reporting defect remediation, test planning, and test cases/script.... (This job is for - SDLC Jobs in MA Boston Manager - (in Boston, MA)) ITS63 DOT Senior Business Analyst 001 -SP Create date: 07-May-2021 Bid Number: BD-21-1030-0P100-0P110-62343 Note: RTR form must be submitted Note: Online Submission hourly rate: $79 to $90 Submission Deadline: 5/13/2021 04:00 PM EST Start Date: 5/24/2021 End Date: 11/23/2021 Client: Department of Transportation Description: The Business An.... (This job is for - SDLC Analytical Skills Jobs in MA Boston Analyst - (in Boston, MA)) ITS63_EHS_FY21_QAANAL_006-VG4 Technical Tester -SP Create date: 30-Mar-2021 Note: RTR form must be submitted. Note: According to doc due date was March 26th, 2021 Note: Email Submission Note: Maximum number of resumes per ITS63 Vendors: 2 Submission Deadline: 4/2/2021 Start Date: 4/12/2021 End Date: 10/11/2021 Client: EHS Description: EOHHS has a hi.... (This job is for - SDLC STLC Jobs in MA Quincy Tester - (in Quincy, MA)) Sr. QA Tester - 73037 Create date: 17-Mar-2021 Candidate must be our W2 Employee. Job Description: Client part of On Assignment & the 2nd largest IT staffing Solutions firm in the country has an opportunity for a Sr. QA Engineer for a remote position for a client based out of Boston, MA. The identified resource will conduct manual testing on various projects wit.... (This job is for - SDLC MS SQL Server Jobs in MA Dorchester Consultant - (in Dorchester, MA)) Quality Assurance Test Lead - 57856 Create date: 05-Mar-2021 Note: * Local candidates Preferred. (Applicants must be currently in the US and work EST hours) Description: The Quality Assurance Test Manager - Lead provides technical expertise in test automation to assist the software development team in improving development velocity with defect free code. This engineer must b.... (This job is for - SDLC Jobs in MA Boston TeamLead - (in Boston, MA)) (Analyst: SDLC, IT Quality Process, System Requirements, Multiple Tasks GXP GAMP in Cambridge, MA)

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