Quality Systems Associate: GMP & Compliance

Charles River Laboratories; 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

Employee and family wellbeing support

Work life balance flexibility

Job summary

Charles River Laboratories in Newark, DE is seeking a Quality Assurance support professional to assist with facility, process, vendor and local validations to ensure GMP compliance and adherence to SOPs. You will review regulated records and prepare audit materials while supporting QA metrics and regulatory inspections.

The role requires a Bachelor’s degree (life science preferred) and at least 6 months in QA or regulated industry; MS Office experience is expected.

Qualifications

• Bachelor’s degree (B.S. / BA / A.) or equivalent, preferably in a life science.
• Minimum of 6 months in a Quality Assurance or regulated industry role.
• Some experience with Microsoft Office® applications.
• Must communicate clearly, effectively and professionally; attention to detail and strong writing skills are essential.

Responsibilities

• Assist/perform facility, process, vendor and local validation activities to ensure GMP and SOP compliance.
• Review SOPs, protocols/batch records, reports and quality records for accuracy and compliance.
• Prepare audit records and countersign as trainee when applicable.
• Support QA metrics analysis and QMS reporting.
• Assist with QA files for sponsor site visits and regulatory inspections.
• Participate in quality improvement initiatives and dashboard analysis.

Skills

Communication

Attention to detail

Writing skills

Clear and professional communication

Education

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

Tools

Microsoft Office

Job description

Charles River Laboratories in Newark, DE is seeking a Quality Assurance support professional to assist with facility, process, vendor and local validations to ensure GMP compliance and adherence to SOPs. You will review regulated records and prepare audit materials while supporting QA metrics and regulatory inspections.

The role requires a Bachelor’s degree (life science preferred) and at least 6 months in QA or regulated industry; MS Office experience is expected.