Quality Systems Specialist – Compliance & Audits

Charles River Laboratories, Inc.; Newark (DE); On-site; USD 26,000 - 36,000; Full time

Benefits offered by this job

Bonus/incentives based on performance

401K

Paid time off

Stock purchase program

Health and wellness coverage

Job summary

Charles River Laboratories, Inc. is seeking a QA professional to assist with facility and process validation, audits, and regulatory compliance at our Newark, DE site. The role supports the QMS and ensures adherence to GMP, ISO standards, and SOPs.

You will review records, participate in inspections, and drive continuous improvement through QA metrics, collaborating with Operations and Quality Management to maintain high standards of quality and compliance.

Qualifications

• Bachelor’s degree in life science or equivalent.
• Minimum 6 months in a Quality Assurance or regulated industry role.
• Strong writing and communication skills required.

Responsibilities

• Assist/perform facility, process, vendor and local validation activities to assure compliance with GMP, ISO, SOPs and QMS.
• Review SOPs, protocols/batch records, reports and quality records for accuracy and regulatory compliance.
• Prepare written records of audits and inspections and participate in QA file preparation for sponsor visits and regulatory inspections.
• Participate in process improvements and dashboard analysis for QMS metric reporting.
• Support QA audits, CAPAs, deviations and change controls as required.
• Assist in regulatory inspections support and management of QA-related documentation.

Skills

Attention to detail

Written communication

Regulatory compliance

Quality Assurance basics

Education

Bachelor's degree in life sciences

Tools

Microsoft Office

Job description

Charles River Laboratories, Inc. is seeking a QA professional to assist with facility and process validation, audits, and regulatory compliance at our Newark, DE site. The role supports the QMS and ensures adherence to GMP, ISO standards, and SOPs.

You will review records, participate in inspections, and drive continuous improvement through QA metrics, collaborating with Operations and Quality Management to maintain high standards of quality and compliance.