Senior Lead Business Analyst

Katalyst Healthcares & Life Sciences - Boston, MA (30+ days ago)


Job Description:
Looking for a Business Analyst for Quality project called EQMS (Electronic Quality Management System).
Global System that was implemented in the last year, however Phase 2 of the project is being initiated to implement a few additional business processes Event Investigations (also referred to as Deviations), CAPA (Corrective and Preventive Actions), and OOS/OOT (Out of Spec, Out of Trend) to a broader global user base.
Similar to LEADs, the document and learning management system, we want a Senior Business Analyst (we can use generic job description), that would specifically work on this project, with some details below. Local, experience with Quality and Pharma experience preferred.

Manage and support system deployment activities with project resources.
Collaborate with business SMEs in local sites and functions for system deployment.
Manage and coordinate IT change management activities.
Coordinate and support user acceptance testing.
Manage translation for training and documentation deliverables with external partners and business SMEs.
Drive new user account request and provisioning.
Support delivery of SDLC documentation including but not limited to functional design specification, system configuration document, design review, traceability matrix.

Strong Subject Matter Expert Experience.
GLOBAL EQMS project experience.
Vast documentation experience with electronic records.
CAPA experience, Quality systems exp, (LIMS, etc.)
Production deployment experience.
Excellent Oral and written communication skills a MUST.