Associate, Compliance & QA – Technology

Job not on LinkedIn

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $52.5k - $81.5k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

🔧 QA Engineer (Quality Assurance)

👻 Ghost score 0%

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WCG

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🏥 Healthcare

💊 Pharmaceuticals

☁️ SaaS

💰 Private Equity Round - WCG on 2019-11

Healthcare • Pharmaceuticals • SaaS

WCG is a global clinical research services and technology company that supports sponsors, CROs, research sites, and institutions across the lifecycle of clinical trials. Founded as a leader in independent ethical review, WCG provides IRB and IBC review, data monitoring committees, site enablement and study start-up services, participant recruitment and retention, and data & insights (including benchmarking, statistical consulting, and AI-powered trial foresight). The company also offers a suite of technology platforms (e. g. , ClinSphere®, eReview Manager, Total Enrollment, Total Feasibility) and large protocol and performance datasets to help design, plan, and run trials more efficiently and compliantly. WCG positions itself as a partner to biopharma and medical research organizations to accelerate trial activation, improve enrollment, and ensure regulatory and ethical compliance.

📋 Description

• Assist and support maintenance of compliance standards and measures across WCG Technology Solutions organizations, including Infrastructure, Information Technology, Software Development and Engineering. • Work alongside WCG Technical Solutions staff to achieve corporate and departmental compliance goals. • Ensure compliance with WCG’s Quality Management System and technology processes. • Engage in the continued development, maintenance, and enforcement of the WCG Quality Management System and quality department standards. • Support maintenance of WCG quality goals, objectives, and process improvements. • Educate WCG staff on quality department standards and best practices. • Author and revise internal technology standards, including IT and Software Development Policies and SOPs. • Support development, validation, implementation, and change management of systems in line with GxP, 21 CFR Part 11/Annex 11, GDPR, and HIPAA. • Develop and review validation deliverables related to implementation or development of WCG systems. • Support investigation of Quality Events, CAPA, deviations, and notes to file; execute assigned compliance tasks within defined timelines. • Conduct internal audits and external vendor qualification audits. • Support external audits through preparation, audit-report review, and finding resolution. • Maintain current knowledge of quality legislation and regulatory compliance best practices. • Perform other duties assigned by the supervisor.

🎯 Requirements

• Bachelor’s degree in a scientific, technical or related field, or equivalent combination of education, skills, and experience to perform the job. • Two (2) to four (4) years’ experience in a quality/regulatory compliance position supporting and contributing to quality assurance projects/assignments. • Knowledge of current regulatory (FDA & ICH) & GCP guidelines as they apply to clinical studies. • Experience in supporting customer/sponsor audits of organizational processes, training, documentation, etc. • Knowledge of 21 CFR Part 11 scope and application and Computerized System Validation processes. • Experience in the execution and documentation of Computerized System Validation efforts of systems used in Clinical Trials. • Experience delivering training materials related to company standards and regulatory requirements. • Ability to contribute to and execute workstreams within multi-departmental projects. • Effective communication (written and oral), organization and interpersonal skills as well as the ability to interact with WCG staff, sponsors, and regulatory agencies as needed. • Demonstrated technical writing skills. • Ability to problem solve and engage in conflict resolutions. • Ability to multitask and to work efficiently and independently. • Travel requirement of 5%–10%.

🏖️ Benefits

• Comprehensive Benefits package - Health, Dental, Vision, Life Disability, 401k with match, and flexible spending accounts • Employee Assistance Programs and additional work/life resources • Referral Bonuses and Tuition Reimbursement • Flexible PTO • Volunteer Time Off to benefit the community • Opportunities for career development with on-the-job training, certification assistance, and continuing education reimbursement