Quality Systems Specialist

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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