The Quality Specialist II, under minimal supervision, performs activities to ensure that Flagship’s laboratory and image analysis programs meet the high-quality standards of our clients and regulatory agencies. This will include; helping to design and build components of the quality management system, managing the day-to-day activities of the Quality Department, such as independently writing and reviewing Standard Operating Procedures (SOPs), reviewing study protocols and associated documentation, writing and reviewing audit questionnaires and audit responses, and assisting during on-site client audits. The Quality Specialist II may also be directly responsible for certain quality sub-systems such as maintaining the vendor management system, hosting client audits, and independently performing internal process audits and study audits. The Quality Specialist II will also be responsible for the application of FDA and CAP/CLIA regulations to Flagship’s quality activities and identifying quality issues and opportunities for improvement of current processes.

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, ability to interact with all levels of the organization and juggle multiple tasks effectively.

Essential Job Functions: