Quality Systems Specialist

A pharmaceutical company in Massachusetts is seeking a Quality Systems Specialist to support quality system activities across internal and external operations. This role focuses on maintaining compliant quality processes, driving continuous improvement, and partnering with cross-functional teams to support a strong culture of quality.

About the Opportunity:

• Schedule: Monday to Friday


• Hours: Standard business


• Setting: Hybrid (at least 3 days a week onsite)

Responsibilities:

• Support quality system activities related to deviations, CAPAs, change controls, investigations, and audit readiness


• Partner with global and site leadership teams to support adherence to Quality Management System principles and related initiatives


• Coordinate revisions to SOPs, forms, and templates for quality systems documentation


• Monitor quality metrics and support Quality Management Review processes and related actions


• Provide guidance to the user community and collaborate with cross-functional teams to maintain a state of control


• Qualifications:


• Bachelor's Degree in a scientific discipline.


• 1-3 years of experience in the Pharmaceutical or Medical Device industry


• Experience working within effective cGMP quality systems, including SOP writing


• Experience with GMP requirements


• Strong collaboration, organizational, and attention-to-detail skills


• Excellent written and verbal communication skills, including presentations to cross-functional groups, senior management, and external stakeholders.


• Ability to work autonomously in a fast-paced environment

Desired Skills:

• Experience with change control, deviations, CAPAs, investigations, supplier notifications of changes, and supplier corrective actions requests


• Exposure to GLP and Google Cloud Platform environments