Laboratory Quality Coordinator – Regulatory Focus, 401k Matching

About the Company

Charles River Laboratories International, Inc. is an American corporation specializing in a variety of preclinical and clinical laboratory services for the pharmaceutical, medical device, and biotechnology industries. With a global network of facilities, we are dedicated to supporting our clients’ research and development efforts, from basic research to regulated safety assessment. Our mission is to accelerate the discovery, development, and safe manufacture of new medicines and therapies.

Job Description

We are seeking a highly motivated and detail-oriented Laboratory Quality Coordinator with a strong regulatory focus to join our team in Wesley Chapel, Florida. This pivotal role involves ensuring our laboratory operations consistently meet and exceed internal quality standards, as well as strict regulatory requirements. The successful candidate will be instrumental in maintaining compliance, driving continuous improvement initiatives, and supporting a culture of quality across all laboratory functions. This is an excellent opportunity for a professional passionate about quality assurance and regulatory affairs within a dynamic scientific environment.

Key Responsibilities

• Develop, implement, and maintain quality management systems (QMS) in accordance with relevant regulatory guidelines (e.g., GLP, GMP, ISO 17025).
• Coordinate and conduct internal audits, identify non-conformances, and track corrective and preventive actions (CAPAs).
• Assist in preparing for and hosting external regulatory inspections and client audits.
• Manage documentation control processes for SOPs, test methods, quality records, and other critical documents.
• Provide training to laboratory personnel on quality policies, procedures, and regulatory requirements.
• Monitor key quality metrics, analyze trends, and report on quality performance to management.
• Investigate quality incidents, deviations, and out-of-specification results, facilitating root cause analysis and resolution.
• Collaborate with laboratory staff to ensure adherence to quality standards in all daily operations.
• Stay current with evolving regulatory requirements and industry best practices.

Required Skills

• Bachelor's degree in a scientific field (e.g., Chemistry, Biology, Biochemistry, Medical Technology).
• Minimum of 4 years of experience in a quality assurance or regulatory compliance role within a laboratory setting.
• Demonstrated knowledge of GLP, GMP, ISO 17025, or other relevant quality regulations.
• Proficiency in developing and maintaining Quality Management Systems (QMS).
• Strong understanding of audit processes, CAPA management, and document control.
• Excellent communication, interpersonal, and organizational skills.
• Ability to work independently and as part of a collaborative team.

Preferred Qualifications

• Master's degree in a scientific or quality-related discipline.
• Experience with electronic Quality Management Systems (eQMS).
• Certification in Quality Assurance (e.g., ASQ Certified Quality Auditor, CQE).
• Experience in a CRO or pharmaceutical development environment.

Perks & Benefits

• Competitive salary and performance-based bonuses.
• Comprehensive health, dental, and vision insurance.
• Generous paid time off and holiday schedule.
• 401k matching program to support your financial future.
• Opportunities for professional development and career growth.
• Tuition reimbursement program.
• On-site fitness center and wellness programs.
• Employee assistance program.

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