Job Title: Quality Assurance Contractor (GCP)

　　Location: Florham Park, NJ - Hybrid schedule

　　Hours/Schedule: M-F, 8 am – 5 PM

　　Compensation: $50-65/hour - There is some flexibility for senior candidates.

　　Type: 12-month contract with potential to extend

　　Must have GCP auditing experience in clinical trials.

　　Overview

　　We are seeking a highly skilled and experienced Quality Assurance professional specializing in Good Clinical Practice (GCP) compliance for a contract position. In this role, you will be responsible for overseeing and ensuring the quality and regulatory compliance of our clinical trials and research projects. Your primary focus will be on GCP-related activities to maintain the highest standards of clinical trial conduct and supporting auditing and inspection activities.

　　RESPONSIBILITIES

　　Ensure that clinical trials are conducted in compliance with GCP principles, and that data generated from these trials are of high quality and integrity.

　　Support GCP regulatory inspections and manage assigned Corrective and Preventive Actions (CAPAs) identified during regulatory inspections.

　　Evaluate the effectiveness of CAPAs and follow-up on audit findings to ensure timely resolution.

　　Provide quality oversight, guidance, and necessary tools for clinical studies and vendor oversight program to maintain compliance with global regulatory standards (i.e., ICH E6, ICH E8, etc.), SOPs.

　　Review clinical trial documentation, processes, and plans to ensure expectations are clear and align with regulatory requirements.

　　Collaborating with Clinical Operations personnel to monitor the performance of vendors to ensure they meet requirements and to identify any risks and propose remediation actions. This involves conducting regular vendor audits (if qualified) or assessments to evaluate the vendor’s compliance with the company’s quality standards.

　　Collaborating with applicable internal departments to assess risks associated with using vendors and implementing risk mitigation strategies as necessary to ensure product quality, data integrity, and patient safety.

　　Provides guidance and support on quality and compliance issues and how to maintain compliance with applicable regulations, guidelines, and company policies.

　　Interprets and evaluates clinical and regulatory compliance requirements to ensure that the company is meeting its obligations.

　　Maintains required knowledge of applicable regulations and government, industry, and company GCP standards and their interpretations.

　　MINIMUM JOB REQUIREMENTS

　　BA/BS in the life sciences, scientific, technical discipline, or related field.

　　At least 3 years of clinical quality assurance or compliance, with a focus on GCP regulations and guidelines, including ICH, FDA, EMA, and PMDA requirements.

　　Experience supporting regulatory GCP inspections.

　　Excellent communication and leadership skills.

　　Detail-oriented with strong analytical and problem-solving abilities.

　　Benefits

　　System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.

　　#M3

　　System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

　　System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.