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Business Systems Analyst (Validation)

Company: Asta CRS Inc.
Location: Reston
Posted on: November 22, 2022

Job Description:

Job Description Job Summary: Our corporate activities are growing rapidly, and we are currently seeking a full-time, office-based Business Analyst (BA) to join our System Validation team. The BA will work with internal business users in other departments to validate third-party software applications. The BA will manage these projects, facilitating and supporting the business users in defining requirements and writing/executing test scripts. Responsibilities : Assist business users in defining user requirements and configuration specifications for regulated activity performed in third-party software applications; Assist business users in developing and executing acceptance test scripts for third-party software applications; Write Validation Plans and Summary Reports for validation projects conducted for third-party software applications; Proactively maintain in-depth knowledge of regulatory requirements and manage 21 CFR Part 11 Compliance Assessments for each regulated third-party software application; Coordinate with vendors and/or service providers contracted to perform validation activities to ensure compliance with SOPs and regulatory guidance; Provide guidance as needed to ongoing risk assessments and/or ensuring procedural controls are in place to mitigate risk and maintain compliance; Conduct internal reviews of validation projects for both third-party and custom systems to ensure compliance with SOPs and regulatory guidance; Assist in gathering evidence during sponsor audits and regulatory inspections. Qualifications : Bachelor's degree in Information Systems, Computer Science or a related field. Excellent communication skills, and ability to foster and maintain relationships with non-technical business users. Excellent writing skills. Knowledge of system validation and software testing methodologies (experience in pharmaceutical GxP environments is a plus). Knowledge of risk management strategies, and adapting testing strategy accordingly. Company Description ASTA Corporate Resource Solutions Inc is one of the Fastest Growing IT Companies in Northern America and the DC Metro Area with its headquarters in Ashburn, Virginia. ASTA CRS is an Information Technology Provider delivering superior quality software development, consulting, and staffing solutions to our client partners. ASTA CRS services are uniquely positioned to support clients in achieving profound efficiencies and relentlessly delivering results. ASTA CRS is a long-time and trusted resource for its clients and partners. Asta CRS, Inc. is an Equal Opportunity Employer M/F/V/D. ASTA CRS is proud to state that we are enrolled with the USCIS for the E-Verification Program.

Keywords: Asta CRS Inc., Reston , Business Systems Analyst (Validation), Professions , Reston, Virginia

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