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

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.

We are seeking Analysts with GAMP 5 experience for our direct client - a pharmaceutical giant in Weston, MA.

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 the client 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. 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.

V. QUALIFICATIONS:

• 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.