What are the responsibilities and job description for the Quality Systems Specialist position at Tandym Group?
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
- 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 GCP environments
Salary : $45 - $54