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Title: Temporary QA Associate
Location: Remote
Type: Full-Time
Workplace: remote
Category: Quality
JobDescription:
Who We Are Vial is a global tech-driven CRO providing next-generation clinical trial management services. The Vial CRO powers its drug discovery arm, Battery Bio, an AI-powered hyper scalable biotech. Battery Bio harnesses Vial’s unique 90% lower cost structure to produce more affordable drug development with efficient, streamlined clinical trials. Our mission is to reimagine the drug discovery process to empower scientists to cure all human disease. We have assembled a talented team of clinical operators, chemists, and innovative thinkers to achieve this vision. Vial is a San Francisco, California-based company founded by Simon Burns in October 2020. Since our founding, we have become a fast-growing company of 100+ employees with over $100 million in funding from esteemed investors including General Catalyst, Box Group, and Byers Capital. Vial is rebuilding the infrastructure to advance research. By deploying technology at every step, we are creating a more efficient future for drug discovery. What You’ll Do The Clinical QA Associate will be responsible for the execution and oversight of GCP QA activities related to clinical trials. This involves working closely with Clinical Operations, Engineering, IT and other supporting areas/development teams to assure management in accordance with FDA regulations, ICH-GCP, SOPs, and all other applicable regulations. Duration: 01 May – 01 September Travel: Expected (25%-50%)Responsibilities
- Lead qualification, routine and for-cause audits of vendors & investigator sites to assess effectiveness of their QMS and compliance to GCP, approved clinical study protocols and contracts
- Conduct Trial Master File (TMF) audits
- Conducts internal audits (systems, processes, vendors, computer system validation)
- Communicates audit findings to audit stakeholders for visibility, as well as collaborating with auditees to ensure appropriate implementation of Corrective and Preventive Action Plans (CAPAs), addressing root causes
- Maintains databases for Investigator Site audit observations and CAPAs; Tracks, reviews, approves, and assesses the adequacy of CAPAs. Provides input and supports observation and CAPA tracking for external Clinical vendors.
- Collaborates with sponsors, vendors, and investigator sites to provide QA support and oversight to clinical studies while assessing compliance with local regulations, GCP/ICH requirements, and SOPs
- Implement Clinical QA plans to meet GCP quality standards, policies, and procedures
- Support continuous improvement activities
- Support oversight/execution of training program to ensure appropriate training of all staff
- Provide Quality oversight to deviation/Quality Incident investigations including root cause analysis and CAPA development and follow through
- Perform other related duties as assigned
Requirements
- 5+ years of experience in a pharmaceutical/biotech or CRO industry. Start-up experience preferred
- Expert knowledge and understanding of ICH GCP and worldwide applicable regulatory requirements
- Experience conducting internal, vendor and investigator site audits
- Experience with software implementation
- Strong organizational skills, ability to multi-task, attention to detail, self-starter, ability to prioritize
- Excellent verbal, written communication, and presentation skills