Sr Clinical Quality Assurance Auditor – REMOTE
Job Description
Your expertise will contribute to ensuring the utmost quality in clinical practices, making a tangible impact on our mission. With competitive pay based on education and experience, this role offers the perfect balance of professional growth and flexibility. You will be provided great benefits such as Medical, Dental, Vision, 401(k), Life Insurance, Health Savings Account, Flexible Spending Account, Competitive Salary, Paid Time Off, Employee Discounts, and Employer paid STD & LTD. Embrace this unique opportunity to shape the future of biotechnology while working from the comfort of your home.
Beacon Therapeutics (USA) Inc: What drives us
If you are passionate about gene therapy and its ability to enhance the lives of patients, then Beacon is a great team to join. We are a diverse, multi-national team of talented people all working together at our sites in the US and the UK, or as a remote contributor. Everyone here, whatever their role or location, plays a genuine part in bringing our treatments to patients. Everyone has a voice, and every contribution makes a difference.
Make a difference as a Sr Clinical Quality Assurance Auditor
As a Sr Clinical Quality Assurance Auditor at Beacon Therapeutics (USA) Inc, you will proficiently conduct Good Clinical Practice (GCP) audits of Clinical Sites, Trial Master Files, and Clinical Vendors, ensuring compliance and excellence in clinical operations. Your role will involve evaluating and tracking quality issues, as well as implementing corrective and preventive actions to enhance our processes. By effectively supporting our internal customers in Clinical Development and Clinical Operations, you will play a critical part in fostering a culture of accountability and continuous improvement. Your expertise will not only help maintain the highest standards of quality but also drive collaboration across teams, solidifying our commitment to integrity and innovation in the biotech industry.
Requirements For This Sr Clinical Quality Assurance Auditor Job
To succeed as a Sr Clinical Quality Assurance Auditor at Beacon Therapeutics (USA) Inc, candidates should possess a robust set of skills and experiences tailored to the demands of the role. Proficient clinical audit experience with Investigator Sites and Trial Master Files (TMF) is essential, along with a strong understanding of Good Clinical Practice (GCP) and US/EU regulations. The ideal applicant will demonstrate proven experience in auditing investigator sites and clinical vendors, showcasing an ability to effectively evaluate and manage issues and CAPAs.
A collaborative spirit is crucial, as you’ll provide responsive customer support to internal departments. Additionally, the ability to work professionally and independently in a remote environment is vital, alongside critical thinking skills for navigating complex, ambiguous situations. Strong written and verbal communication abilities will enable you to clearly articulate observations.
Knowledge of gene therapy is preferred, further enriching the expertise you bring to our innovative team.
Knowledge And Skills Required For The Position Are
- Clinical Audit Experience with Investigator Sites, TMF, Vendors
- Effectively Evaluate and Manage Issues and CAPAs
- Collaborative and responsive customer support to internal departments
- Good Clinical Practice and US/EU Regulations
- Proven experience auditing investigator sites and clinical vendors
- Ability to work professionally and independently in a remote environment
- Critical thinker with the ability to navigate gray areas
- Strong written and verbal communication skills to clearly and effectively explain observations
- Gene therapy knowledge preferred
Join our team today!
If this sounds like the right job for you, don’t wait – apply today to join our team. We look forward to hearing from you!