Quality Assurance Specialist

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CARE

WebsiteLinkedInAll Job Openings

5001 - 10000 employees

Founded 1945

⚕️ Healthcare Insurance

📚 Education

🎯 Recruiter

💰 Grant on 2021-11

Healthcare Insurance • Education • Recruitment

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

• Ensure the highest standards of patient safety and data integrity at clinical research sites through regular quality assurance reviews, site quality support, and assurance compliance with Standard Operating Procedures. • Conduct comprehensive reviews of study-specific regulatory binders and clinical documents to verify they are accurately completed and maintained per GCP standards. • Execute the yearly corporate audit plan, systematically tracking quality assurance audits, monitoring related activities, and preparing detailed outcome reports for management. • Partner directly with research staff and Principal Investigators (PIs) to resolve identified compliance issues, developing, tracking, and monitoring Corrective and Preventative Action (CAPA) plans. • Coordinate and provide hands-on operational support for on-site audits and inspections conducted by external providers, sponsors, and regulatory agencies. • Provide ongoing administrative support to the Quality Department by maintaining internal quality systems, compliance trackers, and operational programs. • Participate in the routine review, drafting, and maintenance of quality assurance Standard Operating Procedures (SOPs) to ensure alignment with evolving regulations. • Act as an internal quality resource to provide ongoing guidance and best-practice recommendations to site personnel and clinical project teams. • Be knowledgeable of evolving GxP guidelines. Ability to critically think, eagerness to learn, and commitment to ensuring compliance. Knowledge of and able to interpret regulatory guidance’s such as 21 CFR Part 11/ Part 312, ICH GCP E6 (R3). • Promote a culture of inspections readiness and continuous improvement. Be flexible to work with risk-based audit agendas and shifting priorities. • Create and deliver training on Quality and Improvement activities. • Support completion of RFP/RFI (Request for proposals/information). • Willingness to learn and engage with digital technologies. • Provide AI project quality support and consultation. • Support other activities related to the management of QMS and accuracy of data. • Support GxP and non GxP quality issues and/or projects needing quality consultation and support.

🎯 Requirements

• 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 • Portuguese and English language speaker required, Spanish is a plus.

🏖️ Benefits

• Paid Time Off (PTO) and Company Paid Holidays • Medical, dental, and vision insurance plan options