North America Service Quality Specialist

Work Location:

Burlington, Massachusetts

Department: LS-AS-BAG Sale Region South B

Recruiter:
Katherine Hall

Hiring Manager:
Jami L Stoll

This information is for internals only. Please do not share outside of the organization.

• In this role you will support the North America Bio Monitoring 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.

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

• 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.

RSREMD

The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment.

Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.