IT Quality Analyst for Commercial Applications -GAMP 5- ANALYST - CONTRACT OPPORTUNITY

Hi, We are seeking Analysts with GAMP 5 experience for our direct client- a pharmaceutical giant in Weston, MA. If interested in this opportunity kindly send updated resume to and please call me at 732 549 2660. TITLE: IT Quality Analyst for Commercial Applications Contract : 3- 6 months Location: Weston, MA Client: Pharmaceutical company I. GENERAL SUMMARY: As a member of the IT Quality & Regulatory Compliance team, the IT Quality Analyst for Commercial Applications helps to define, plan, and perform duties that support major system development life cycle activities, including validation review and change control approval of IT Commercial systems. II. PRINCIPAL DUTIES & RESPONSIBILITIES: • Approve system life cycle deliverables 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 IT Commercial systems. • Represent IT Quality & Regulatory Compliance on all IT Commercial projects in support of SDLC activities. • Consult on the authoring and conformance of SDLC deliverables and activities in regard to corporate SOPs and current regulations. • Provide guidance, training, and support to IT Commercial personnel in their SDLC efforts, to ensure compliance. • Provide quality assurance oversight for system related issues • Assist in the completion of Change Control activities according to theclient standards. III. JOB DEMANDS: This job requires the IT Quality Analyst for Commercial Applications to attend department and user meetings, system assessment meetings, trainings, and other essential tasks. The IT Commercial Regulatory Analyst must maintain a professional manner in representing the company and in working with its agents and associates. The IT Commercial Regulatory Analyst 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. IV. JOB IMPACT: The IT Quality Analyst for Commercial Applications’ role is essential in maintaining IT Commercial Systems that are compliant with corporate requirements and good business practices. IV. QUALIFICATIONS: A. Essential: • Thorough knowledge of IT Controls methodologies, including GAMP5 and ITIL • Extensive experience with IT Commercial Applications (e.g. CRM systems, Salesforce, etc.) • Strong knowledge of SDLC Agile methodology • Experience with Veeva CRM and other systems • Excellent communication skills, both verbal and written • Detailed knowledge of the IT system development life cycle and software quality assurance in a regulated environment • Knowledge of general software and database concepts • Knowledge of infrastructure technology and platforms • The ability to work both independently and with teams at various levels in the organization • The ability to work in a very dynamic environment with a clear sense of urgency. • Excellent organizational skills and attention to detail and accuracy • Three or more years working in an IT SQA or Quality role Note: This description is not intended to be all-inclusive or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned. Thanks, Srilatha (Sri) Vinjamuri Technical Recruiter INTEGRATED RESOURCES, INC. 4 Ethel Road, Suite 403B Edison, NJ 08817 IT REHAB CLINICAL NURSING Inc. 5 0 0 0 – 2007- 2013 (7th Year) Direct: (732) 549 2660 Tel: (732) 549-2030 x 127 Fax: (732) 549-5549 All your information will be kept confidential according to EEO guidelines. A Few Words About Us Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing. With todays growing demand for talented and well qualified professionals, its more important than ever to partner with a company that employs innovative measures to meet your demands. Our expert team of highly trained counselors work hand in hand with every client forming a partnership of understanding and commitment. Our clients know that they can rely on us for prompt response times and reliable staff to meet their workforce demands. Our employees know that they can trust our support for their career development and personal growth. IRI is proud to be JCAHO Certified by the Joint Commissions of Health, MBE Certified by the State of NJ and the National Minority Supplier Diversity Council (NMSDC) and SBE Certified by the State of NJ. We have been honored by the following: Top 100 Diversity Owned Business in NJ for 2007, 2008 and 2009 Top 500 Privately-Held Business in the US Top 500 Diversity Owned Business in the US Top 100 Subcontinent Asian American Business in the US We have also been listed to the Inc. 5000 List of fastest-growing, privately-held companies in the US in 2007, 2008, 2009 and 2010 and honored as an Emerging Business of the Year finalist by NJ BIZ in 2009.