Business System Analyst

 Biztegy Analytics    California City, CA
 1 month ago

Job Description

Sr. Business Systems Analyst - IT

Foster city , CA


PHARMACEUTICAL/BIO-TECH/LIFE SCIENCE EXPERIENCE PREFERRED


IT GXP (Validation Process) EXPERIENCE


Local on-site Senior Business Analyst with IT GxP process and Business Process implementation experience. The individual we are looking is a seasoned Senior Business Analyst with strong core skills, including communication, leadership, taking the initiative, and driving for results with little support from other BA team members. This person will need to be able to work in a very fast-paced and dynamic environment, yet, bring organization and control to the track(s) of BA work they manage.


Mastered Skill:

• Implement advanced strategies for gathering, reviewing and analyzing requirements • Prioritize requirements and create conceptual prototypes and mock-ups • Master strategic business process modeling, trace ability and quality management techniques • Apply best practices for effective communication and problem-solving • Creates clear and concise documentation


Requirements:

  • 7+ years analyst experience preferred.

• Ability to elicit business requirements and translate into technical documents • Understanding of GAMP 5, 21 CFR part 11, and Computer System Validation • Experience authoring and updating SOP's. Experience in navigating deviations, CAPA's and CC's.

  • Experience with complete software development life cycle.

• Experience designing and reviewing test cases. Experience with QA (GxP) process methodology • Knowledge of SharePoint or similar collaboration portal • Self-starter with strong problem solving skills • Excellent verbal and written communication skills.


Responsibilities:

• Partner with cross-functional stakeholders (i.e.: Technical team, Validation/Qualification team and Business counterparts, etc.) to elicit, analyze, and translate information to create Business Requirement , User Requirements, and/or Technical Requirements • Act as a liaison between technical teams, and the business community, including managing communications between business stakeholders and technical teams • Lead effort to obtain approvals for all types of Requirements • Manage user change requests and change process • Design comprehensive test plans to test the quality of software and business processes • Work with IT Technical team, Business counterparts, etc. to gather information to create User Acceptance Test Strategy documents • Coordinate and manage user acceptance testing by providing test schedules, planning, test data, detailed test scripts and document test results • Lead effort to obtain approvals for UAT Testing Summary, including the creation of the summary itself.

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