A pharmaceutical company in New Jersey 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 GCP environments

Job application