North America Service Quality Specialist

Merck•Burlington, MA

17h

About The Position

In this role you will support the North America BioMonitoring Service organization. You will support the maintenance and improvement of the local QMS in compliance with applicable requirements, ISO 9001-related requirements, regulations and external requirements.

Requirements

Bachelor's Degree in any discipline.
2+ years of Quality Management Systems experience.
1+ years of QA experience.

Nice To Haves

Auditing knowledge according to the LS Audit Standard (040091MP).
Experience working within the cGMP regulated pharmaceutical industry.
ISO 9001-based Quality Management System knowledge.
Good communication skills.
Organizational and Time Management skills.
Team Building skills.

Responsibilities

Serve as the primary focal point for the local Quality Management System (QMS), driving organizational compliance with ISO 9001 requirements and strategic quality initiatives.
Manage the lifecycle of quality documentation, records, and procedural implementations across the organization.
Develop and deliver quality training programs and communications to ensure continuous team understanding of quality topics and standards.
Facilitate the execution and follow-up of key quality processes, including Risk Management, Change Control, Complaints, Deviations, and CAPAs.
Support and coordinate local internal self-inspections, supplier audits, customer audits, and external regulatory or certification body inspections.
Develop, execute, and monitor action plans resulting from audit findings, inspections, and quality deviations.
Maintain Key Quality Indicators (KQIs) and heat map data to conduct ISO 9001 process performance and Integrated Management Reviews.
Drive ongoing QMS improvements through trend analysis while acting as the liaison between internal departments, regional quality teams, customers, and regulatory authorities.