Lead Quality Assurance Specialist – GMP & ISO Compliance

Keystone Industries; Gibbstown (NJ); On-site; USD 80,000 - 100,000; Full time

Benefits offered by this job

Weekly Pay

Comprehensive Health Coverage

401(k) Retirement Plan

Paid Time Off & Holidays

Employee Assistance Program

Career Development Opportunities

Job summary

Keystone Industries in Gibbstown, NJ is seeking a Quality Assurance Specialist to ensure products meet GMP, ISO 13485 and regulatory requirements. You will coordinate QA activities, lead internal audits, and support CAPA and change management.

The role emphasizes documentation, training, and supplier qualification, with opportunities to influence quality systems and participate in management reviews.

Qualifications

• Minimum 5 years of Quality Assurance and ISO Quality System experience.
• FDA cGMP knowledge for medical devices; ISO 13485 experience is required.
• Strong analytical and problem-solving skills with documentation focus.

Responsibilities

• Lead QA activities for new projects across divisions and coordinate regulatory compliance.
• Perform batch record reviews and manage CAPA, deviations, and change control.
• Maintain and improve Quality Management System elements and generate management reports.
• Assist with risk assessments, supplier qualification, and internal audits.

Skills

Quality Assurance

Regulatory knowledge

Auditing

Documentation

Leadership

Education

Bachelor’s degree in a technical field

Tools

MasterControl

Job description

Keystone Industries in Gibbstown, NJ is seeking a Quality Assurance Specialist to ensure products meet GMP, ISO 13485 and regulatory requirements. You will coordinate QA activities, lead internal audits, and support CAPA and change management.

The role emphasizes documentation, training, and supplier qualification, with opportunities to influence quality systems and participate in management reviews.