Job description
- Smart and Hungry: We simplify complex problems. We are never satisfied and we love to learn.
- Find a Way: We find solutions for any problem. We must collaborate to win.
- Get the Right Stuff Done: The right strategy and execution to positively impact patients’ lives.
- Respect: Open communication, refer to the expert but respects equal say at the table.
The Quality Specialist II will be joining a small team in a dynamic, fast-paced environment that is involved with all aspects of Flagship’s business, including clinical trials, CAP/CLIA, FDA, and medical device development. The candidate should possess basic knowledge of FDA and CAP/CLIA regulations, superior organization skills, exceptional attention to detail, the ability to interact with all levels of the organization and juggle multiple tasks effectively.
Essential Job Functions
- Assist in maintaining components of Flagship’s Quality Management System
- Assist with the day-to-day operations of the QA Department
- Supports QA Department in facilitating GCP/GCLP and CAP/CLIA activities
- Write/review SOPs, study procedures, client audit questionnaires, and client audit responses with minimal supervision
- Maintain certain quality management sub-systems such as;
- Vendor management system
- Equipment management system, ensuring equipment is qualified appropriately
- Issue management system, ensuring issues are handled appropriately
- Assist during on-site client audits
- Perform internal audits and clinical study audits with minimal supervision
- Assist QA team members and Flagship internal customers to identify quality issues and improve operational processes
- Other duties, projects as assigned
Basic Qualifications
- Bachelor’s Degree in a science-related discipline preferred.
- 3-5 years of experience in Quality Assurance
- Knowledge and application of FDA, CLIA, and GCP/GCLP regulations and FDA guidance
- Experience with technical writing
- Proficient in MS Office (Word, Excel, and PowerPoint at an intermediate level)
- Superior organization skills with a focus on attention to detail and accuracy
- Ability to manage/prioritize multiple tasks simultaneously
- Ability to work independently in a very fast-paced, changing environment
- Exceptional interpersonal and communication skills, both verbal and written
- Ability to interact/communicate effectively with team members across all departments and levels of the organization
- Quick learner with excellent judgment and problem-solving skills
- Ability to work independently with limited direction and as part of a team
- Upbeat attitude and willingness to learn
- Fluent in English, both verbal and written
Preferred Qualifications
- Experience in a regulated scientific, medical device, or healthcare area with direct QA/QC experience and direct application of FDA regulations and guidances
- Experience with many aspects of Quality Management
About Flagship Biosciences:
At Flagship Biosciences, we are dedicated to improving the health of patients everywhere by pioneering the most advanced computational tissue image analysis, clinical support, and diagnostics services that help pharmaceutical companies develop the solutions to treat, manage, and cure the world’s most challenging medical conditions. Flagship develops its analytic and infrastructural technology in-house, providing truly unique capabilities not available anywhere else in the market. None of this can be done without a strong, talented team of people dedicated to moving our business forward.
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