System Business Analyst Resume Lexington, MA - Hire IT People

SKILLS:

EXPERIENCE:

Confidential

Lexington, MA

System Business Analyst

Responsibilities:

Confidential

IT Validation Consultant

Boston, MA

Reviewed Validation records. Developed validation plans and reviewed risk/compliance (Biotech Domain)
Archived Documents, Reviewed and Authored IT SOPs, Assisted with Infrastructure Qualification

Confidential

Burlington, MA

Senior Validation Consultant

Responsibilities:

Developed detailed validation plans for EDC system to cover testing strategy, validation and Functional risks and planned validation activities for IQ, OQ and PQ.
Performed custom Reporting testing on Cognos application for clients.
Worked on Oracle database and wrote SQL queries to retrieve data from the database.
Created test cases and scripts for Java Technology - base web application to adequately verify that the software is performing as intended.
Created requirements Traceability Matrix to ensure that all requirements have been adequately tested for EDC(InForm), Central Designer and Central Coding.
Wrote defects as they were found using Jira and internal application.
Performed Smoke testing and Functional testing testing.
Created and maintained a library of test cases in SharePoint document management system.
Served as a resource and provided information as requested to internal and external sources on validation operation.
Attended walkthrough meetings for requirement reviews and provided feedback to the team.

Confidential

Waltham, MA

Validation Consultant

Responsibilities:

Generated validation documentation, which included validation plans, requirements and specification, testing plans, IQ, OQ and PQ protocols.
Performed training related to validation projects, software application and SOPs
Revised testing cases, protocols and traceability matrix as necessary based on project team feedback.
Created test cases based on functional and user specs and executed test scripts to ensure system release functions as expected.
Worked closely with the Project team to ensured test scripts are ready for IQ,OQ and PQ.
Performed Impact analysis on minor and major release of our products
Performed manual test on system QA environment and functional specs for validation.

Confidential

Cambridge, MA

Analyst Associate II

Responsibilities:

Proficient in basic analytical techniques in a QC/commercial setting (CE, ELISA, IEF, Western Blot, Plate Readers, Incubator, Flow Cytometry, ect (LIMS).
Wrote change controls and deviations, Authorized, revised and reviewed SOPs.
Assisted with Validation reports and other documentation as needed.
Performed equipment calibrations and monitors testing equipment.

Cambridge, MA

Analyst Associate II

Responsibilities:

Boston, MA

QC Compliance Specialist II

Responsibilities:

Reviewed and entered data obtained from QC and report abnormalities in Access.
Maintain trends of product data and controls. Generate charts, monitor data trends and make appropriate observations to management.
Write SOPs, Batch records, Validation reports and other documentation as needed.
Assisted with QC Development of analytical methods for new drug
Worked with CE, HPCL, ELISA, IEF, Western Blot, Plate Readers, Incubators, ect