QMS and Reporting Specialist - Hybrid, Cambridge, MA

Specialist / Senior Specialist - Global Quality Systems, Audits & Inspections, Cambridge, MA Hybrid

Position Overview

The Quality Management Systems (QMS) and Reporting Support Specialist will support multiple quality system initiatives while providing reporting, analytics, and process improvement support. This individual will work closely with cross functional GxP stakeholders to support quality data management, deviation investigations, reporting activities, and continuous improvement initiatives across the quality organization.

Key Responsibilities

Deviation Training Program & Investigation Support

• Support the implementation of deviation investigator training programs using adult learning principles and practical application techniques.
• Develop training materials, including case studies, templates, and guidance documents, to improve investigation quality and consistency.
• Collaborate with Quality Assurance and deviation owners to establish sustainable support models, including coaching sessions, office hours, and knowledge resources.
• Analyze training effectiveness metrics, including investigation quality, cycle times, and rework trends, to identify opportunities for improvement and scalability.

Quality Metrics, Reporting & KPI Enhancement

• Support the development and delivery of quality scorecards, dashboards, and KPI frameworks.
• Perform data aggregation, trend analysis, and root cause focused assessments across deviations, CAPAs, and change controls.
• Support routine and ad hoc reporting activities for quality management reviews and quality system governance forums.
• Ensure data accuracy, consistency, and integrity across reporting deliverables.
• Provide project management support for quality system initiatives, including timelines, deliverables, and stakeholder coordination.

QMS Process Support & Technology Enablement

• Assist with process mapping, gap assessments, and continuous improvement initiatives across Quality Management System processes.
• Support data governance, data quality, and data cleanup activities within electronic quality systems.
• Utilize approved digital and AI enabled tools to enhance analytics, reporting, and quality record completeness while maintaining compliance and data integrity requirements.

Qualifications

• Bachelor's degree in Life Sciences, Engineering, or a related discipline.
• 3 to 5 years of experience supporting GxP Quality Systems, Quality Assurance operations, or QMS programs.
• Strong understanding of GMP, GLP, GCP regulations, and ICH guidelines.
• Demonstrated experience with:
  • Quality Management System processes
  • Quality metrics, dashboards, and KPI development
  • Data analysis and trending using Excel, Power BI, or similar tools
  • Electronic Quality Management Systems (eQMS)

Preferred Qualifications

• Experience with electronic Learning Management Systems (LMS) and Document Management Systems (DMS).
• Experience supporting change management and organizational development initiatives.
• Experience working within regulated pharmaceutical, biotechnology, medical device, or life sciences environments.

Key Competencies

• Strong analytical and process improvement mindset.
• Advanced Excel and data analysis skills.
• Strong project management and organizational capabilities.
• Excellent communication, facilitation, and stakeholder management skills.
• Ability to influence and collaborate across functions without direct authority.
• Strong technical writing and documentation skills.
• Experience leveraging AI enabled tools while maintaining GxP compliance and data integrity standards.

Estimated Min Rate: $35.70
Estimated Max Rate: $51.00

What's In It for You?
We welcome you to be a part of the largest and legendary global staffing companies to meet your career aspirations. Yoh's network of client companies has been employing professionals like you for over 65 years in the U.S., UK and Canada. Join Yoh's extensive talent community that will provide you with access to Yoh's vast network of opportunities and gain access to this exclusive opportunity available to you.

Benefit eligibility is in accordance with applicable laws and client requirements. Benefits include:

• Medical, Prescription, Dental & Vision Benefits (for employees working 20+ hours per week)
• Health Savings Account (HSA) (for employees working 20+ hours per week)
• Life & Disability Insurance (for employees working 20+ hours per week)
• Met Life Voluntary Benefits
• Employee Assistance Program (EAP)
• 401K Retirement Savings Plan
• Direct Deposit & weekly epayroll
• Referral Bonus Programs
• Certification and training opportunities

Note:

Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply.

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a…