GLP QA Specialist

Details for the position are as follows:

• 8 month contract to start with the possibility of extension or conversion depending on performance and budget.
• Rate: $60 an hour
• Location: Rahway, NJ - Hybrid 3 days/week onsite (Tuesday and Weds onsite core days, choice of Monday or Thursday for third onsite day)

Job Description:

We are seeking a highly organized and detail-oriented Quality Assurance Specialist to oversee and enhance our quality assurance processes. This role is pivotal in ensuring that our study data are collected, documented, and reported in full compliance with GLP, GCP, and other relevant regulatory requirements. The successful candidate will play a key role in the preparation of final study reports for submissions to regulatory agencies such as CVM, USDA, and international bodies, ensuring that our research meets or exceeds all government and internal compliance standards.

Key Responsibilities:

• QA SOP Management: Oversee the development, maintenance, and continuous improvement of Quality Assurance Standard Operating Procedures (SOPs).
• Training Documentation: Manage and update QA training materials, ensuring all documentation is current and in compliance with industry standards.
• Audit Coordination: Schedule and coordinate auditor visits for both Contract Research Organizations (CRO) and internal inspections, ensuring thorough and timely audits.
• Documentation Archival: Maintain organized, secure archives of QA documentation to support regulatory compliance and audit readiness.
• Performance Metrics: Develop and monitor QA metrics to track performance and drive continuous process improvements.
• Audit Report Management: Create and distribute comprehensive lists of outstanding QA audit reports, ensuring timely follow-up and resolution.
• Regulatory Compliance Support: Assist in establishing systematic processes to ensure that all study data collection, documentation, and reporting adhere to GLP, GCP, study protocols, SOPs, and industry guidance.
• Final Report Preparation: Play an integral role in completing final study reports for GCP and GLP studies, supporting submissions to CVM, USDA, or international regulatory agencies by ensuring a thorough and expeditious audit process.
• Internal Inspections: Support internal facility inspections of Client Animal Health research facilities to ensure adherence to QA standards.

Required Skills:

• Bachelor’s degree with a minimum of 3 years of relevant experience.
• Proven expertise in managing QA SOPs and training documentation.
• Strong organizational and coordination skills, particularly in managing schedules for CRO and internal inspections.
• Demonstrated ability to maintain comprehensive QA documentation archives.
• Experience in developing and monitoring QA performance metrics.
• Proficiency in creating and managing audit report processes.
• Ability to assist in internal facility inspections and contribute to continuous improvement initiatives.