Quality Systems Specialist — QA & Compliance

Charles River Laboratories; Newark (DE); On-site; EUR 27,000 - 31,000; Full time

Job summary

Charles River Laboratories is seeking a QA/Regulatory Compliance professional to assist with facility, process, vendor and local validation activities, ensuring GMP and ISO compliance. The role involves reviewing quality records, supporting audits, and contributing to QA metrics and regulatory inspection preparations.

The ideal candidate has a life science background with at least 6 months in QA or regulated industry, and strong writing and communication skills.

Qualifications

• Education: Bachelor's degree (B.S. / BA.A.) or equivalent, preferably in a life science.
• Experience: Minimum of 6 months in a Quality Assurance or regulated industry role.
• Other: Some experience with Microsoft Office applications. Clear, effective communication and strong writing skills are essential.

Responsibilities

• Ensure Charles River's compliance with applicable regulations and corporate policies; communicate risks to supervisor.
• Review SOPs, protocols/batch records, reports, quality and regulated records for accuracy and compliance.
• Prepare written/audited records of audits and inspections; sign records as a trainee where allowed.
• Participate in process improvements and QA file preparation for sponsor site visits and regulatory inspections.
• Assist with QA metrics collection via QMS and with Quality Management Review preparations.
• Support regulatory inspections as required.
• Approve customer test reports and participate in reagent release activities as applicable.
• Perform facility and equipment record reviews and maintain logbooks.

Skills

Attention to detail

Strong writing skills

Effective communication

Microsoft Office

Education

Bachelor's degree (B.S. / BA.A.) or equivalent

Job description

Charles River Laboratories is seeking a QA/Regulatory Compliance professional to assist with facility, process, vendor and local validation activities, ensuring GMP and ISO compliance. The role involves reviewing quality records, supporting audits, and contributing to QA metrics and regulatory inspection preparations.

The ideal candidate has a life science background with at least 6 months in QA or regulated industry, and strong writing and communication skills.