Job description

Quality Specialist: To support the Quality Assurance function in driving compliance and continuous improvement in a highly regulated industry.

Summary of Responsibilities

• Provide input on company procedures and policies to ensure and maintain industry compliance with applicable regulations, ICH GCP Guidelines and other regulatory and compliance requirements
• Provide Quality Management System (QMS) oversight to ensure the proper implementation and maintenance of QMS throughout the conduct of all clinical studies and associated systems, including Trial Master File (TMF), computer systems and training
• Contribute to the development of SOPs and quality assurance guidance documents and processes
• Manage the SOP revision and distribution process according to established timelines, guidelines and procedures, including document control standards and electronic filing
• Manage and ensure training requirements and records maintenance for staff and study teams as appropriate
• Assist in developing and comply with company audit plans and schedules
• Assist in conducting internal audits and vendor qualification audits
• Assist in scheduling, planning and hosting client audits and regulatory inspections
• Provide interpretation and consultation to clinical study teams on regulations, guidelines, policies and procedures
• Assist with the identification and management of quality issues
• Manage computer system validation documentation
• Present educational programs and provide guidance to clinical operations staff on compliance procedures

Qualifications

• In depth knowledge of ICH-GCP Guidelines
• Working knowledge of FDA and appropriate regulations and guidelines
• Knowledge of the clinical trials process and Trial Master File regulatory/ICH GCP requirements
• Minimum 3 years of quality/regulatory compliance background in pharma/biotech and medical device industries, with a hands-on role in quality assurance operations and quality systems

Job Types: Part-time, Contract

Pay: $75.00 - $90.00 per hour

Benefits:

• Flexible schedule

Schedule:

• Monday to Friday

Work Location: Remote

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