Quality Assurance Specialist

Job not on LinkedIn

🔥 13 hours ago

🇺🇸 United States – Remote

💵 $70k - $90k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🔧 QA Engineer (Quality Assurance)

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 0%

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CARE

WebsiteLinkedInAll Job Openings

5001 - 10000 employees

Founded 1945

🍽️ Food & Beverage

🏥 Healthcare

📦 Logistics

💰 Grant on 2021-11

Food & Beverage • Healthcare • Logistics

CARE is a boutique provider of high-quality, accredited carers for the Aged Care and Early Learning industries. It specializes in matching experienced professionals, recent graduates, and students with job vacancies in these sectors, facilitating rewarding career placements. CARE aims to support clients and carers by providing effective staffing solutions and contributing to their success in the industry.

📋 Description

• Monitor quality and compliance of clinical work at traditional trial sites and decentralized trials • Ensure patient safety and data integrity through regular quality assurance reviews • Interpret and implement standard QA procedures • Review study-specific regulatory binders and clinical documents for GCP compliance • Execute the yearly corporate audit plan • Track quality assurance audits and related activities • Prepare detailed audit outcome reports for management • Partner with research staff and Principal Investigators to resolve compliance issues • Develop, track, and monitor Corrective and Preventive Action (CAPA) plans • Coordinate and support on-site audits and inspections by external providers, sponsors, and regulatory agencies • Maintain internal quality systems, compliance trackers, and operational programs • Review, draft, and maintain quality assurance SOPs • Advise site personnel and clinical project teams on quality and compliance best practices • Monitor evolving GxP guidelines and interpret 21 CFR Part 11, 21 CFR Part 312, and ICH GCP E6 (R3) • Promote inspection readiness and continuous improvement • Create and deliver training on quality and improvement activities • Support RFP/RFI completion • Engage with digital technologies • Provide quality support and consultation for AI projects • Support QMS management, data accuracy, and GxP/non-GxP quality projects

🎯 Requirements

• Excellent working knowledge of medical and research terminology • Excellent working knowledge of federal regulations and good clinical practices (GCP) • Attention to detail • Ability to communicate and work effectively with a diverse team of professionals • Strong organizational skills, including prioritizing, delegating, directing, supporting, and evaluating others’ work • Strong verbal and written communication skills • Strong computer skills using clinical trials databases, IVR systems, electronic data capture, MS Word, and Excel • Ability to balance tasks with competing priorities • Demonstrated decision-making skills • Curiosity and passion to learn and innovate • Ability to communicate possible risks and complete tasks • Ability to maintain a positive attitude under pressure • High self-motivation and energy • Ability to work independently in a fast-paced environment with minimal supervision • Client service mentality • Experience supporting multiple sites and identifying gaps • Experience with internal and external audits, FDA, GCP, and SOPs • Bachelor’s degree • 2 years of experience in Quality Assurance • 4 years of experience in Clinical Research working in a compliance or GCP-relevant role • Ability to travel, including potential international travel • Care Access is unable to sponsor work visas at this time

🏖️ Benefits

• Paid Time Off (PTO) and Company Paid Holidays • 100% Employer paid medical, dental, and vision insurance plan options • Health Savings Account and Flexible Spending Accounts • Bi-weekly HSA employer contribution • Company paid Short-Term Disability and Long-Term Disability • 401(k) Retirement Plan, with Company Match