Senior Quality Systems Lead — GMP Compliance & Audits

Charles River Laboratories; Newark (DE); Sur place; USD 39 000 - 55 000; Plein temps

Avantages offerts par ce poste

Bonus incentives

401K

Paid time off

Stock purchase program

Health and wellness coverage

Employee and family wellbeing program

Résumé du poste

Charles River Laboratories is seeking a Quality Assurance professional to ensure compliance with federal, state, and local regulations, GMP, ISO, and SOPs. The role includes QA file preparation for client audits, coordinating regulatory inspections, and driving continuous improvement initiatives.

The ideal candidate has a life sciences degree and 8+ years in QA, with strong writing and communication skills. Extensive experience with MS Office, Excel, and Access is preferred.

Qualifications

• Bachelor's degree in life sciences or equivalent.
• Minimum 8 years in a Quality Assurance role or regulated industry.
• Clear communication, strong writing skills, and attention to detail are essential.
• Proficiency with Microsoft Office applications; Excel and Access experience helpful.

Responsabilités

• Ensure compliance with applicable regulations and corporate policies.
• Perform QA/system audits and document reviews.
• Lead preparation for client audits and regulatory inspections.
• Review SOPs, protocols, deviations, and CAPAs for accuracy and compliance.
• Coordinate quality metrics reporting and QA support for continuous improvement.

Connaissances

Attention to detail

Communication skills

Strong writing skills

Regulatory knowledge

Formation

Bachelor's degree in life sciences

Outils

Excel

Access

Microsoft Office

Description du poste

Charles River Laboratories is seeking a Quality Assurance professional to ensure compliance with federal, state, and local regulations, GMP, ISO, and SOPs. The role includes QA file preparation for client audits, coordinating regulatory inspections, and driving continuous improvement initiatives.

The ideal candidate has a life sciences degree and 8+ years in QA, with strong writing and communication skills. Extensive experience with MS Office, Excel, and Access is preferred.