Quality Control Analyst, Analytical Methods
The QC Senior Analyst, Analytical Methods will support critical analytical method implementation workstreams in support of the facility start-up plan. These workstreams include analytical instrument qualification, critical reagent management, execution of technical protocols, and supporting the implementation of programs and procedures in a new Quality Control laboratory located in Durham, North Carolina. The work schedule for this position will be based on the manufacturing production schedule and will primarily be split shift (12pm - 8pm) with the possibility of working weekends when needed.
- Maintain and operate analytical instrumentation for flow cytometry and other bioassays
- Analyze data; interpretation of data within given parameters
- Investigate out of specification or unexpected results and study outcomes
- Escalate and assist in the resolution of complex issues
- Independently develop, author, and execute protocols, reports and other related documents
- Communicate effectively with peers, and demonstrate collaboration across different functions
- Support the implementation and execution of training programs and processes for less experienced QC Analysts
- Draft and review technical documents
- Bachelor’s degree required, preferably in a life science discipline with 3-4 years relevant experience
- Advanced hands-on experience with various analytical techniques primarily flow cytometry
- Scientific knowledge and direct experience with analytical method transfer requirements and processes
- Advanced technical writing and problem-solving ability
- Ability to work independently in a high-paced team environment, meet deadlines, and prioritize work from multiple projects.
- Must be able to work onsite daily and willing to have a flexible schedule during peak times, which may include supporting critical operations outside of normal work hours, as needed.
- Advanced ability to communicate effectively with peers, department management and cross-functional peers