Merck KGaA

North America Service Quality Specialist

Burlington, Massachusetts, United States Full time
Quality

Merck KGaA is the source of truth for this posting and owns the application process. We surface normalized context and market comparison you won't find on the original listing.

About this opportunity

Work Your Magic with us!  Start your next chapter and join MilliporeSigma.

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.

Your Role:

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.

QMS Strategy & Compliance: Serve as the primary focal point for the local Quality Management System (QMS), driving organizational compliance with ISO 9001 requirements and strategic quality initiatives.

Documentation & Record Control: Manage the lifecycle of quality documentation, records, and procedural implementations across the organization.

Training & Communication: Develop and deliver quality training programs and communications to ensure continuous team understanding of quality topics and standards.

Core Quality Process Management: Facilitate the execution and follow-up of key quality processes, including Risk Management, Change Control, Complaints, Deviations, and CAPAs.

Audit & Inspection Coordination: Support and coordinate local internal self-inspections, supplier audits, customer audits, and external regulatory or certification body inspections.

Corrective Action Implementation: Develop, execute, and monitor action plans resulting from audit findings, inspections, and quality deviations.

Metrics & Performance Reviews: Maintain Key Quality Indicators (KQIs) and heat map data to conduct ISO 9001 process performance and Integrated Management Reviews.

Continuous Improvement & Stakeholder Relations: Drive ongoing QMS improvements through trend analysis while acting as the liaison between internal departments, regional quality teams, customers, and regulatory authorities.

 

Who You Are:

Minimum Qualifications:

Bachelor's Degree in any discipline.

2+ years of Quality Management Systems experience.

1+ years of QA experience.

 

Preferred Qualifications:

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.

Pay Range for this position: $84,300 - $126,500 ​

The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. For more information click here .

RSREMD

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!

Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!

Job details

Seniority
Not listed
Function
Quality
Therapeutic area
Not listed
Location
Burlington, Massachusetts, United States
Employment type
Full time

How this role compares

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