About Flagship. 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.

Our Cultural Values

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, refers to the expert but respects equal say at the table.

Job Classification: Full-time, Exempt

Position Summary

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

Assist in designing and building components of Flagship’s Quality Management System
Perform the day-to-day operations of the Quality Department
Supports Quality Department in facilitating GCP/GCLP and CAP/CLIA activities
Independently write/review SOPs, study procedures, client audit questionnaires, client audit responses
Maintain certain quality management sub-systems such as;
- Vendor management system, planning and conducting vendor audits
- Equipment management system, ensuring equipment is qualified appropriately
- Issue management system, ensuring issues are handled appropriately
Assist/host during on-site client audits
Independently perform internal audits and clinical study audits
Assist QD 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
3-6 years of experience in Quality Assurance
Knowledge and application of FDA, CLIA and GCP/GCLP regulations and FDA guidances
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

Company Benefits

Health (100% company-paid for employees only on the lowest base & HSA plan)
Dental (100% company-paid for employees only)
Vision (100% company-paid for employees only)
Medical and dependent care FSA
Company-paid STD & LTD
Company-paid Basic Life & AD&D
Voluntary life, AD&D, and accident insurance
Generous PTO/Sick Leave & Flex PTO
8 company-paid holidays
Paid time off for bereavement, jury duty, voting
401k (match up to 4%)
Employee assistance program
Legal Shield & ID Shield
Education assistance
Professional development program
Hybrid work schedule (4 days in office, 1 day remote)

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.

Flagship Biosciences, Inc. jobs

QA Specialist II