Clinical Quality Assurance Specialist II
Welcome to Thermo Fisher Scientific, a global leader in serving science and improving lives. We are currently seeking a highly motivated and experienced Clinical Quality Assurance Specialist II to join our team. As a Clinical Quality Assurance Specialist II, you will play a crucial role in ensuring the quality and compliance of our clinical products, supporting our mission to provide innovative solutions for our customers. If you are a detail-oriented individual with a strong understanding of quality control and regulations in the clinical industry, we encourage you to apply and help us make a difference in the world of healthcare.
- Develop and maintain quality assurance processes and procedures for clinical products in compliance with industry standards and regulations.
- Conduct thorough reviews and audits of clinical product documentation to ensure accuracy and adherence to quality standards.
- Collaborate with cross-functional teams to identify and resolve quality issues and implement corrective actions.
- Maintain a comprehensive understanding of relevant regulations and industry standards and ensure adherence to them in all aspects of clinical product development and manufacturing.
- Monitor and analyze quality control data to identify trends and areas for improvement, and make recommendations for process enhancements.
- Provide training and guidance to colleagues on quality assurance processes and procedures.
- Participate in external audits and inspections, and ensure timely and effective responses to any findings.
- Contribute to the continuous improvement of quality systems and processes, identifying opportunities for increased efficiency and effectiveness.
- Communicate effectively with internal and external stakeholders to provide updates on quality assurance activities and address any concerns or questions.
- Maintain accurate and up-to-date documentation of all quality assurance activities and support documentation for regulatory submissions.
- Act as a subject matter expert on quality assurance matters, providing guidance and support to colleagues as needed.
- Stay informed on industry developments and changes in regulations, and proactively implement necessary changes to maintain compliance.
- Collaborate with the clinical product development team to ensure quality is built into product design and development from the beginning.
- Other duties and responsibilities as assigned by management.
Bachelor's Degree In A Relevant Scientific Field (E.g. Biology, Chemistry, Pharmacy) Or Equivalent Work Experience.
Minimum Of 3-5 Years Of Experience In A Quality Assurance Role Within The Pharmaceutical Or Biotech Industry.
Strong Knowledge Of Good Clinical Practice (Gcp) Regulations And Guidelines.
Experience Conducting Audits And Inspections Of Clinical Trial Sites And Vendors.
Excellent Communication And Interpersonal Skills, With The Ability To Effectively Collaborate With Cross-Functional Teams And Communicate Quality-Related Issues To Management.
Documentation
Training
Data Analysis
Auditing
Quality Control
Root Cause Analysis
Compliance
Risk assessment
SOP Development
Quality Metrics
Gmp Regulations
Fda Guidelines
Communication
Conflict Resolution
Emotional Intelligence
Leadership
Time management
creativity
Attention to detail
Teamwork
Adaptability
Problem-Solving
According to JobzMall, the average salary range for a Clinical Quality Assurance Specialist II in Fishers, IN, USA is between $63,000 and $86,000 per year. However, this can vary depending on factors such as experience, education, and specific job responsibilities.
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Thermo Fisher Scientific is a U.S.-based provisioner of scientific instrumentation, reagents and consumables, and software and services to healthcare, life science, and other laboratories in academia, government, and industry.
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