Quality Systems Specialist

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