Business Analyst / validation Analyst

Please send the resumes to careers@starkassociatesllc.com or

Contact: +1 848-300-0022

Role: Business Analyst / validation Analyst

Duration: Long term

Location: Boston, MA

Primary Responsibilities

As an Analyst, you will help refine and grow the capabilities of current systems, driving continuous improvement to meet Biogen needs. You will serve as tactical IT liaison to the business through building and fostering a partnership, being able to demonstrate strong understanding of the business area and its supporting technology as well as broad understanding of overall business unit. Work with Product Lifecycle Management (PLM) system users and stakeholders to understand and document capabilities, issues and challenges of current system and processes.

Provide weekly status updates on progress towards deliverables and milestones.

Experience working in a regulated environment in life science industry. (preferred)

Good knowledge of Software Development Life Cycle (SDLC) and Computer System Validation.

Experienced in preparing and reviewing Test Plans, Validation protocols (Installation Qualification – IQ, Operational Qualification – OQ, Performance Qualification – PQ, UAT Protocols), Test Summary Report and Requirement Traceability Matrix (RTM).

Write documentation for all aspect of the computer systems validation lifecycle, in accordance with FDA regulations Particularly 21CFR Part 11.

Review Documentations Such as User Requirements Specifications, Functional Requirements specifications, Application, Configuration, Qualification Protocols along with Pre execution review and Post execution review of Test scripts.

Involved in complete manual testing of the application by executing all the test cases and to check the functionality of the Application.

Managed and organized requirement coverage, Test Case Management and Defect Management using and communicating between Team Lead, Developers to resolve the technical issues.

Responsible for coordinating with team members in locating, tracking, organizing and verifying validation documentation for cGMP compliance, GxP and regulatory requirements.

Implemented Good Documentation Practices (GDP) to review and approve the Test Scripts pre-execution as well as post approval.

Experienced working in partnership with ITQA to ensure that documentation is planned executed to meet SDLC and regulatory requirements.

Develop, plans and report validation activities on validation summary reports.

Manage across multiple business functions to gather required information and drive consensus where required.

Escalate issues to leadership for engagement and resolution

Participate in assessing key priorities and needs for an effective PLM system.

Skills/Experience

• Overall 2 to 5 years’ experience.

• Experience with Oracle Agile processes and systems. Version 9.3.1 or above (Nice to have)

• Strong Analytical skills, Strong project management skills

• Excellent facilitation, collaboration, verbal and written communication skills

• Ability to work independently, drive consensus and work under the direction of Sr. Business Analyst.

• Pharma/Life science experience is a must.