| Our client in Titusville, NJ is seeking a Validation Consultant for their Sales and Medical Affairs Validated Systems RESPONSIBILITIES: - Change Requests - Oversees the Change Request (CR) process and leads weekly CR meetings, Maintains CR log, Works with teams to ensure CR forms are completed correctly and ensure all necessary activities are performed to satisfy the process from initiation of the CR through to completion of the CR, Distributes and collects CR signatures - Project Documentation - Provides templates to teams and advises teams on the necessary content of documents, Works with teams to determine documentation milestone criteria to ensure that teams include documentation deliverables in project plans, Performs 1st review of all documentation before it goes to compliance management, Reconciles requirements entered into Quality Center to requirements contained in documentation, Distributes and collects signatures on all documentation, Maintains documentation numbering system, Maintains the documentation storage areas (electronic and hardcopy) - Testing Activities (Change Request and Project) - Reviews test scripts in Quality Center to ensure the test creation process is followed, Verifies all requirements have an associated test script, Works with teams to reconcile pass/fail test results within Quality Center and testing documentation, Generates traceability matrices and works with teams to reconcile the data contained within the trace matrices - Quality Center Administration and Training - Performs basic administrative tasks for a limited number of users, Performs Quality Center training for a limited number of users, - SOPs - Maintains SOP log for CSV SOPs - For non-validated systems - System admin for Sharepoint documentation site, Coach project teams on necessary documentation on SDLC, Participates in the collection of SLDC adherence metrics REQUIREMENTS: 1. Skilled with Computer Systems Validation 2. Microsoft Word & Excel 3. Mercury Quality Center 4. MUST BE A US CITIZEN OR PERMANENT RESIDENT ABLE TO WORK ON OUR W2 WITHOUT SPONSORSHIP TO QUALIFY - NO CORP TO CORP CANDIDATES COMPENSATION/COMMENTS: Up to $55/hr (DOE) - If an offer is made, a 7 year criminal background check, education verification, employment verification, and 2 professional references will be required. Candidate must be pass all screenings to be hired. Local candidates are encouraged to apply as there is no relocation reimbursement. Please send your resume as an MS Word attachment to VIET@APRCONSULTING.COM and refer to JOB# TO-2853 when responding. Thank you! VIET HUYNH | APR CONSULTING senior recruiter 3200 el camino real #160 irvine, ca 92602 e : viet@aprconsulting.com p : 714-544-3696 x-203 p : 800-294-2187 f : 714-544-4587 MIS Ntwk Assoc Mtg Dates: Mar 8th - Tues Reg Mtg - 6 pm - Berman Larson Kane Offices, Paramus - DO NOT use GPS for directions - Bring 15 copies of your resume Mar 29th - Tues Dinner Mtg - Recruiter Night Out - Moderator - Bob Larson Berman Larson Kane - Wanda Megaro G45 Cnsltg - Ralph Cetrulo FYI Bus Solutions |
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