Job Description :
Senior Quality Specialist
6 Months
Marlborough, MA

The Sr. Quality Specialist is accountable to provide the following support and activities:
Supports 1st and 2nd shift and providing direct QA support to ensure Quality Management timelines are met in support of manufacturing and business needs
Provides input and solutions to management regarding issues impacting Quality Assurance
Participates in Quality Assurance projects and initiatives, as appropriate
Responsible for the review of Quality System documentation including Non-conformance Reports (NCRs) and appropriately dispositions affected materials in VISTA
Provides guidance and partnering for investigations of discrepancies or failures related to manufacturing and control systems
Assists in evaluating root cause, rick, assigning appropriate corrections, and ensures documentation is complete and accurate
Reviews Production Batch Records for devise and reagent products as part of in-process and final product release
Utilizes the business inventory systems (VISTA) and TrackWise to evaluate and analyze batch record discrepancies and issues
Manages workload to ensure manufacturing schedules are met
Reviews/approves documentation changes in Document Change Orders and Work Flows
Responsible for review and approval of plans, protocols, and reports (Validations, Qualifications, Stability, etc

Education:Bachelor''s Degree Required