North America Service Quality Specialist
$84,300–$126,500 year
On-siteBurlington, Massachusetts, United States
Job Summary
Support the North America BioMonitoring Service organization by maintaining and improving the local Quality Management System (QMS) in compliance with ISO 9001 requirements and applicable regulations. Manage the lifecycle of quality documentation, records, and procedural implementations while developing and delivering training programs to ensure team understanding of standards. Facilitate key quality processes including Risk Management, Change Control, Complaints, Deviations, and CAPAs, and coordinate internal self-inspections, supplier audits, and external regulatory inspections. Develop and monitor action plans for audit findings and maintain Key Quality Indicators to drive continuous improvement through trend analysis. Act as the liaison between internal departments, regional teams, customers, and regulatory authorities to execute corrective actions and performance reviews.
Required Qualifications
- Bachelor's Degree in any discipline
- 2+ years of Quality Management Systems experience
- 1+ years of QA experience
- External applicants must be eligible to work in the US
Desired 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
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